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August 2024

Volume 24, Issue 8

The U.S. Food and Drug Administration’s (FDA) MedSun program provides this monthly newsletter to inform patients and patient advocates about FDA information on medical device related topics. The MedSun program, launched in 2002 by the FDA’s Center for Devices and Radiological Health (CDRH), uses a secure online reporting system to receive medical device adverse event reports from a network of over 300 clinical facilities across the United States. MedSun sites work collaboratively with the FDA to assist in detecting, understanding, and sharing information concerning the safety of medical products and play a critical role in the FDA’s postmarket surveillance efforts.

Safety Communications

• Update: Evaluating Plastic Syringes Made in China for Potential Device Failures 7/18/24

Highlighted Recalls

• Baxter Issues Urgent Medical Device Recall for Volar System Single-Patient Use Circuit 7/16/24
• Bausch + Lomb/Synergetics Removes Certain I-Pack Injection Kits Due to Potential Non-Sterility 7/15/24
• Baxter Removes Life2000 Ventilator Due to Potential Failure of Battery Charging Dongle 7/15/24
• Hamilton Medical Issues Correction for HAMILTON-C6 Medical Ventilators to Address Risk of Failed Ventilation Restart 7/11/24
• Megadyne Issues Correction for MEGA SOFT, MEGA SOFT DUAL and MEGA 2000 Patient Return Electrodes to Limit Risk of Pediatric Burns 7/11/24
• Inspire Medical Systems Removes Inspire IV Implantable Pulse Generator due to Manufacturing Defect That Can Result in System Malfunctions 7/11/24
• Radiofrequency (RF) Coils Correction: Philips North America Updates Use Instructions For SENSE XL Torso (1.5T And 3.0T) Coils Due to a Potential Issue Where the Coil Heats Up During MRI Scans, Possibly Leading to Thermal Injury 7/8/24
• Quick Link to Medical Device Recalls

Letters to Health Care Providers

• Safe Use of Megadyne Mega 2000 and Mega Soft Patient Return Electrodes 7/31/24
• Disruptions in Availability of BD BACTEC Blood Culture Media Bottles 7/10/24
• Do Not Use Medtronic NIM Standard and Contact EMG Endotracheal Tubes 7/9/24

Guidances

• Final: Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder
• Final: Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
• Final: Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56)
• Draft: Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies
• Draft: Essential Drug Delivery Outputs for Devices Intended To Deliver Drugs and Biological Products
• Draft: Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers

FDA News Release

• Laboratory Developed Tests: FAQs
• FDA Rare Disease Innovation Hub to Enhance and Advance Outcomes for Patients
• FDA Guidance Provides New Details on Diversity Action Plans Required for Certain Clinical Studies
• CDRH Announces Expansion of the Total Product Life Cycle Advisory Program
• A Lifecycle Management Approach toward Delivering Safe, Effective AI-enabled Health Care

Highlighted Reports

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

Type: Sealant, polymerizing

Manufacturer: Baxter Healthcare Corp.
Brand: PREVELEAK Surgical Sealant
UDI-DI: 05413765583582
Model: ADS201808
Lot: HA240106
Ref: ADS201808

Event: The cardiothoracic surgeon requested to use a new product (PREVELEAK) for an open-heart case. The vendor, who was present in the case, had brought in a sample of the product, which was in a box that looked the same as the box that the sterile product was packaged in. Before the case, a registered nurse took the product from the core refrigerator and placed it on a cart in the operating room. During case, the surgeon asked for the product. The vendor had placed the sample product in the same area as the sterile product. When the surgeon requested the PREVELEAK, she touched one of the packages and the vendor said, "Do not open that one, it is my sample product". The registered nurse opened the product which vendor had not touched. At the end of the case, the vendor realized that the opened product was indeed the sample product, which was labeled “nonsterile sample.” Now, the patient must be followed closely to prevent and monitor for any systemic or cardiac infection that may result due to having a nonsterile product placed on his sutures. The user facility identified the following issues:

• The vendor should not bring in sample products into the operating room suite.
• The sample product was in the same looking packaging as the actual product for use, which caused confusion.
• There were no packaging differences to differentiate the sample from the sterile package.
• The sticker with a sample warning was on only one side of the box.

Type: Catheter, intravascular, therapeutic, short Term less than 30 days

Manufacturer: SVS LLC
Brand: PremierPro
UDI-DI: 00811220034795
Model: 31TB20100
Ref: 31TB20100

Event: This facility is experiencing multiple issues in multiple lots with the PremierPro TrueSafe Comfort Blood Control IV Catheter. Reports contain all gauge catheters. Complaints include:

• The catheter would not move forward.
• The catheter withdrew early, causing the vein to blow.
• Accidental leakages are occurring.
• The catheter does not connect to tubing connection well.
• During pressure injection imaging technique, the catheter and connection disconnect.
• The IV would not withdraw after starting, so the entire device was pulled out of the patient's arm to withdraw the needle.

Type: System, hemodialysis, remote accessories Manufacturer: Baxter Healthcare Corp. Brand: Auto-Effluent Accessory Lot: 23L0801 Ref: 115370 Event: A new setup for continuous veno-venous hemofiltration (CVVH), a short term, hospital treatment that removes waste and fluid from the blood when a patient’s kidneys aren’t working properly, was put up. Staff found Auto-Effluent fluid leaking at the connection site. The CVVH machine alarm sounded due to a fluid leak being detected in the tray. The source was from the Auto-Effluent tubing where the connection screws together. Staff could not tighten the connection. Staff recommended reviewing other sets for a possible manufacturing defect.

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. The 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: Electrosurgical, cutting and coagulation, and accessories

Manufacturer: Symmetry Surgical Inc.
Brand: Bovie
Lot: 0322Z
Cat: AA01

Event: During a pediatric surgery, the patient was masked down for a lysis of penile adhesion (cutting away of scar tissue that connects the foreskin to the glans). When the surgeon used the Bovie High Temperature Fine Tip Cautery, it took a minute to activate and to heat up. Once it warmed up enough, the surgeon started the procedure. The first assistant student noticed the sponge in their hand started turning black and felt warm. They placed the sponge on the portable surgery stand and an ember formed and caught on fire. The surgical tech tossed the sponge on the floor to avoid further spread. The fire was then put out safely with no harm to the patient or others.

Type: Stopcock, I.V. Set

Manufacturer: ICU Medical
Brand: High Pressure Stopcocks (3-Way, Luer lock off) for umbilical lines
Lot: 13707329 (x3), 13689691
Other: 42353-01

Event: A set of twins had the same event occur two days in a row. Both infants had fluid leaking from their umbilical venous catheter (UVC) devices. We were unable to determine if the crack was present before the valves controlling the flow of liquid (stopcocks) were removed from the original packaging, or if excessive pressure was used by someone on two different infants, two days in a row, at two different times of day. I have worked with the stock room to have the 3-Way stopcocks removed from our supply in both of our neonatal intensive care units. Supply chain ordered a new 4-Way stopcock and was made available on supply carts. The infection prevention staff were alerted to monitor both infants for infection, which did not develop. We have had no issue after this change was made.

FDA Meetings, Conferences, and Workshops

• Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A 8/7/24
• University of Georgia’s International Biomedical Regulatory Sciences Program/FDA 11th Annual Medical Device Regulations Conference 8/21/24
• In Vitro Diagnostic Products (IVDs) - MDR Requirements, Correction and Removal Reporting Requirements, and Quality System Complaint Requirements 8/22/24
• FDA Grand Rounds: Advancing blood safety and patient health in HIV/AIDS through FDA’s research on viral genome surveillance, diagnostic technologies, and biomarker discovery 9/12/24
• FDA Omics Days 2024 - Precision in Practice: Regulatory Science, Best Practices, and Future Directions in Omics 9/12/24
• 14th Annual Global Summit on Regulatory Science 9/18/24 – 9/18/24
• Developing Implanted Brain-Computer Interface Clinical Outcome Assessments to Demonstrate Benefit 9/19/24 – 9/20/24
• Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility of Medical Devices 11/6/24

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

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