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May 2023

Volume 23, Issue 5

The U.S. Food and Drug Administration’s (FDA) MedSun program provides this monthly newsletter to inform patients and patient advocates about FDA-related information on a variety of topics, including new products the FDA has authorized for marketing, significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment, and other information of interest to patients and patient advocates.

The MedSun program, launched in 2002 by the FDA’s Center for Devices and Radiological Health (CDRH), involves the reporting of problems with medical products from a network of approximately 300 hospitals, nursing homes, and home health facilities around the United States. MedSun sites work collaboratively with the FDA to assist in detecting, understanding, and sharing information concerning the safety of medical products. MedSun uses a secure, online reporting system for reporting problems with the use of medical devices and plays a critical role in the FDA’s postmarket surveillance efforts.

Recalls

• Fresenius Kabi USA, LLC Recalls Ivenix Infusion System for Fluid Leak That May Delay or Interrupt Treatment 4-19-23
• Abbott Recalls the Readers used with the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems for Risk of Extreme Heat and Fire 4-12-23
• Datascope/Getinge recalls Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected Shutdown After PCBA Communication Loss 3-31-23
• UPDATE on Adverse Event Reports for Essure 3-31-23
• See Medical Device Recalls for more information.

Safety Communications

• Evaluation of Safety Concerns with Certain Dental Devices Used on Adults 3-30-23
• Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks 4-21-23
• UPDATE: Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls 4-13-23

Guidance Documents

• Final: Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions
• Final: Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act

Highlighted Reports

The reports that follow represent a cross section of device-related events sent by MedSun Reporters during the prior month. The reports are presented as submitted by MedSun reporters and, in some instances, have been summarized and/or edited for clarity.

Type: Introducer, Catheter

Manufacturer: Teleflex Inc.
Brand: Arrowg+ard Blue Mac Two-lumen Central Venous Access Catheter
Cat #: CDC-21242-XCN1A

Event Description: Patient (pt) had multiple known allergies and underwent allergy test following recent anaphylactic reaction after intubation. Surgery cancelled and allergy testing done, which revealed CHG (Chlorhexidine gluconate) allergy. Two months later, pt returned to OR. After central line placed, pt developed hypotension; treated for anaphylaxis. Suspected source was the central line chlorhexidine coating. The patient was prepped with betadine for both line insertions. The line was removed and a new non-coated CHG line was inserted. The decision was made to proceed with the surgical procedure. The pt required 125 mg of Solu-Cortef and had already rec'd Decadron for postoperative nausea and vomiting prior to an anaphylactic episode.

(Left) All Arrow+ard Blue MAC Two-Lumen Central Venous Access Kit Cath-Gard (Arrow) catheters are impregnated with chlorhexidine and silver sulfadiazine. They do not contain minocycline or rifampin. (Right) All Spectrum Central Venous Catheter Trays (Cook Medical) have catheters impregnated with mincocycline and rifampin. They do not contain chlorhexidine or silver sulfadiazine.

Type: Set, Administration, Intravascular

Manufacturer: Carefusion 303, Inc.
Brand: Alaris, Smartsite
Model #: 11532269
Lot #: (10) 22105087
Cat #: 11532269

Event Description: During Durvalumab infusion, the patient's spouse noticed liquid on the floor. Losarb tubing had a small puncture in the tubing and liquid was leaking from the tubing onto the floor. The infusion was immediately paused. Tubing patched with gauze and coban. The infusion was then completed within a few minutes after the patch job. The patient did not receive the full dose of Durvalumab since some had leaked onto the floor. It is unknown how much fluid leaked and how much was infused into the patient. The physician and chemo pharmacy were both made aware.

Type: Set, Administration, Intravascular

Manufacturer: Carefusion 303, Inc.
Brand: Alaris, Smartsite
Model #: 2426-0007
Lot #: 23019108
Cat #: 2426-0007

Event Description: When priming primary tubing with NS (normal saline) using a 250ml bag to be used as KVO (keep vein open), Alaris Infusion Set with three Smartsites had a major leak at the Y-site for Secondary tubing. The RN immediately stopped the process of priming the tubing and notified charge nurse of the faulty primary set of the tubing. Three tubing leak/failures were reported within a week related for this lot/item number.

Type: Suture, Nonabsorbable, Synthetic, Polypropylene

Manufacturer: Covidien
Brand: Surgipro Ll 6. 0
Model #: VP-706-X-2
Lot #: D1c1730y

Event Description: The patient was undergoing cardiac valve surgery, ascending aortic aneurysm repair with 32 mm gel coated conduit with 27 ovalis Medtronic bioprosthetic coronary button reimplantation (right and left). When the surgeon was suturing the new valve in place, the suture broke. Another suture, of the same kind, was brought in and it too broke during placement. At the end of the case, the surgical field was dry. Patient was taken to ICU immediately post op. Upon arrival to the ICU, a large amount of bloody drainage was noted coming from the chest. The patient had to be returned emergently to the OR for exploration. The surgeon found the suture had broken at the left coronary button site anastomosis. The Surgipro 6-0 was replaced entirely, and patency of the anastomosis site was restored. Approximately 500 ml blood was encountered in the mediastinum when the patient's chest was re-opened. The patient has had no other complications since this event and is progressing as expected.

Type: Bottle, collection, vacuum

Manufacturer: Cardinal Health 200, LLC
Brand: Suction Canisters
Lot #: J211-602
Cat #: 65651-515

Event Description: Suction canister bases and lids delivered to floor from hospital supply. It was noted that the lids did not correctly fit the bases, resulting in the suction canister to not function properly. Hospital supply manager made aware. Manufacturer contacted, and they are retrieving a sample for inspection. Lot# in the warehouse is good: confirmed it is J211-602.

Photo of a red suction canister top that is askew from its base. The translucent white plastic canister inside is visible just under the portion of the lid that is raised on the left side of the photo.

Type: Tubes, Gastrointestinal (And Accessories)

Manufacturer: Avanos Medical, Inc.
Brand: Cortrak 2Nasogastric/Nasointestinal Feeding Tube
Model #: 46053
Cat #: 40-9551TRAK2

Event Description:  Family made the patient (pt) a DNR/DNI (Do Not Resuscitate/Do Not Intubate). The pt had severe oropharyngeal dysphagia and was not able to take in oral nutrients. Even though this pt was DNR/DNI, the family wanted restorative treatment via nasogastric (NG) tube feeding to see if the pt could get strong enough to come home. For the entire stay, pt was agitated and would pull out IVs and pull at other tubes and foley catheter. Once family consented to the NG tube, the care team tried to manually insert the NG with a nasal bridle and the pt was agitated and very combative. In order to complete this procedure, six team members were needed to restrain the pt. Restraints were ordered due to the pt pulling at tubes and not following commands. After tube placement, nurses auscultated air in abdomen and pt aspirated GI contents back. X-ray NG placement verification x1: IMPRESSION: Pt is obliqued during the examination. Suspect coiled feeding tube in a hiatal hernia terminating in the mid to distal stomach however repeat examination will be performed to confirm location. Bedside RN calls Radiologist to confirm "okay to use," Repeat x-ray to be done per Radiologist MD. X-ray NG placement verification x2: IMPRESSION: Feeding tube appears to be looped within a hiatal hernia and extends inferiorly at the GE junction terminating in the left mid abdomen likely within the mid to distal stomach. Images were taken for placement verification and bedside RN called radiologist to confirm "okay to use" NG. Once tube feeding was initiated, pt was placed on BiPAP for increased agitation. The pt's condition declined and rapid response called, stat Xray ordered, and tube feeding stopped. A bronchoscopy was completed, and it was noted that the NG tube was placed in the lung and tube feeding was going to the lung (received tube feedings for several hours). The NG was removed and the next day, the family decided on comfort care and the pt expired post BiPAP removal.

Neonatal and Pediatric Reports

These reports describe medical device events involving neonatal or pediatric patients, or those events involving a medical device that is indicated for use in neonatal and pediatric patient populations. FDA defines pediatric patients as those who are 21 years of age or younger (that is, from birth through the twenty-first year of life, up to but not including the twenty-second birthday) at the time of the diagnosis or treatment.

Type: Ventilator, Emergency, Powered (Resuscitator)

MFR: Mercury Enterprises, Inc.
Brand: Neo-Tee T-Piece Resuscitator
Model#: 10-50838
Cat#: 10-50838

Event Description: Called to delivery of baby and upon setting up emergency airway equipment, the Neo-Tee resuscitator PEEP valve was malfunctioning. This has happened before multiple times with this piece of equipment which is single use. The problem seems to be the PEEP valve’s metal spring and the orange plastic screw cap used to set the PEEP sticks - or this time would not hold the PEEP pressure at all. The user had to grab a new Neo-Tee urgently and that one had same issue but the user was able to unscrew orange cap and rethread it on and the PEEP pressure worked.

Links to FDA CDRH Databases and Other Information Sources

• Database of registered medical devices and manufacturers (Reg & Listing)
• Global Unique Device Identification Database (GUDID)
• Medical Device Recalls database
• Medical Device Safety
• MedSun: Medical Product Safety Network

Contact Us

Email: MedSun@fda.hhs.gov
Telephone: 800-859-9821
Fax: 800-859-1292

U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993