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October 2023
Volume 23, Issue 10
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.
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Podcast: – “Toward Improving Race and Ethnicity Data in Healthcare” |
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“Toward Improving Race and Ethnicity Data” is the latest episode of the Health Equity Forum’s podcast series. It discusses RAISE: the Real-world Accelerator to Improve the Standard of collection and curation of race and ethnicity data in healthcare. Rear Admiral Richardae Araojo speaks with Susan Winckler, Chief Executive Officer of the Reagan-Udall Foundation (RUF) for the FDA, and Carla Rodriguez, RUF Director of Research. The podcast is hosted by the FDA Office of Minority Health and Health Equity.
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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.
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Type: Tube Tracheostomy and Tube Cuff
Manufacturer: Covidien LP
Brand: Shiley
Model#: 6CN75H
Lot #: 23B0726JZX
Cat #: 6CN75H
Event Description: A patient had two events of sudden tracheostomy cuff failure. The pilot balloon would not stay inflated on a ventilated patient over the course of two staffing shifts. Each time, the patient required emergent tracheostomy tube replacement. In the most recent event, I noticed that the pilot line had detached from the syringe port inside the pilot balloon. After emergent removal of the device and stabilization of the patient, we noted the cuff that had been inside the patient was still intact. Looking at a replacement cuff repair kit, it does not appear to us that the cuff inside the patient was at fault for the failure. Additionally, the pilot line was visibly detached inside the balloon, which we presume was the cause of the failure. It is very concerning that this occurred twice inside of 24 hours to the same patient. The doctor noted we have had other tracheostomy tube failures recently and thinks it is likely the devices have the same manufacturer problem.
Type: Electrosurgical, Cutting & Coagulation & Accessories
Manufacturer: Stryker Corp.
Brand: Neptune E-Sep
Model#: 0703047000
Lot #: 214520
Cat #: 0703-047-000
Event Description: This facility has had multiple events with this device as described below.
Event #1: At a point during surgery, the patient suffered a 1cm laceration from the surgical pencil. The surgical pencil wasn’t placed back into the holster, resulting in an inadvertent activation when someone either leaned over it or placed another device on top of it that pushed the activation button and resulted in a patient injury.
Event #2: The surgical pencil was in use intermittently during a hernia repair. The surgical pencil was resting on the surgical field although a single holster was present. The resident working on one side of the patient, laid the surgical pencil onto the patient. Almost immediately, the attending surgeon on the opposite side of the patient inadvertently leaned against the surgical pencil, pressing the activation button, resulting in a 2cm laceration to the right lower quadrant of the abdomen. One stitch was required.
Event #3: Upon removing the surgical drapes, we discovered the patient had a burn on the right upper quadrant of the abdomen. The surgical pencil had not been placed in the plastic holster. The surgical pencil was laying on the patient and activated when a member of the OR team leaned up against it.
Event #4: The patient was undergoing an aortoiliac angiogram. An inadvertent superficial skin injury occurred at the left lower abdominal quadrant. It was repaired with 4-0 Monocryl suture.
Event #5: The patient was undergoing a complex surgery. During the case, we believe a hot surgical pencil tip touched the patient’s skin, resulting in a small, superficial injury. We are removing rocker switch surgical pencils and replacing them with push-button style instead.
Type: Probe, Radiofrequency Lesion
Manufacturer: Relievant Medsystems
Brand: Intracept
Model#: FG 0060
Lot #: 127320123
Cat #: RLV AK05
Event Description: The patient was undergoing an L4- L5 vertebral radio frequency ablation. While trying to gain access to the space needed for the peak material, the instrumentation broke off in the L5 vertebral body. Once the trocar was in the posterior aspect of the L5 vertebral body, the bevel tip stylet was removed from the cannula and the curved cannula assembly with the nitinol J- stylet was inserted. The spin wheel was rotated counterclockwise permitting excursion of the J-stylet. We then attempted to advance the curved cannula assembly using a mallet in 1-2 mm increments. Severely sclerotic bone was observed. We attempted to remove the J- stylet, but it was stuck in the bone. The spin wheel was rotated clockwise to remove the J-stylet. The peak sheared off in the pedicle and the rest of the assembly, including the J-stylet, was removed. Approximately 2cm of the peak was sheared off and left in the right L5 pedicle. When the instrumentation break was noted, the L5 procedure was aborted. No attempts were made to remove the peak material. L4 was completed without complication.
Type: Orthopedic Stereotaxic Instrument
Manufacturer: Medtronic Navigation, Inc.
Brand: Medtronic Percutaneous Pin
Model#: 9733235
Lot #: 2023051138
Cat #: 9733235
Event Description: While attempting to attach the device to the stealth impactor instrumentation, the surgeon discovered the attachment peg on the pin was too wide and would not fit. Another pin of the same size but different lot number was opened, and this peg was the correct size. The Medtronic representative was in the room during the procedure and compared an unopened pin of the same lot as the defective one with the opened pin and found that the pegs looked as if they were the same size. There was only one pin left in the core with this lot number, and it was pulled. The surgeon confirmed that if the defective product was used, it could have caused harm to the patient by possibly getting stuck which would have required it to be cut out of the bone.
Type: Device, Monitoring, Intracranial Pressure
Manufacturer: Medtronic PS Medical, Inc.
Brand: Becker
Lot #: 226072075, 226111243, 2258052
Cat #: 46128, 46129
Event Description: We have had multiple reports of leakage from various points on the Medtronic Becker external ventricular drain system. We noted leaking at connection sites and below the drip chamber. Luer locks have unexpectedly disconnected, causing breaks in sterility. Because the defect places all involved patients at increased risk for infection, we have implemented close clinical monitoring.
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Neonatal and Pediatric Reports |
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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.
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Type: Laryngoscope, Rigid
Manufacturer: Flexicare Medical Ltd.
Brand: ProVu Video Laryngoscope
Model#: 040-07-0035U
Event Description: Our Life Flight department received a brand-new Video Laryngoscope device. Upon connecting the device to power to charge the battery, some personnel perceived a burning smell in the air. After checking the area, they noticed the new device was burned out, causing the unit to melt its plastic casing. The device was not in patient use at the time of the event, and there was no personnel harm. The additional devices in this purchase order have been removed from service until further investigation.
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Emergency Preparedness and Medical Devices: Supply Chain Recommendations for Health Care Providers |
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During natural disasters and other emergency situations, medical devices may be exposed to fluctuating power, contaminants, or unusual levels of heat or humidity. There also may be disruptions in the delivery of devices or critical components and impacts on the device supply chain. The FDA encourages medical device stakeholders to engage in preparation activities to minimize potential disruptions to patient care. Effective preparations can help ensure that critical supplies continue to be delivered in a timely and efficient manner.
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FDA Meetings, Conferences, and Workshops |
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Links to FDA CDRH Databases and Other Information Sources |
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U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993 |
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