BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNMED LLC

    MDR report key: 13981302 · Received April 1, 2022

    Report

    Report Number
    1314417-2022-00012
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    March 2, 2022
    Report Date
    April 1, 2022
    Manufacturer
    SUNMED LLC
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLASTIC WRAP COULD BE A POTENTIAL CHOKING HAZARD, COULD BE INHALED OR SWALLOWED. BASED ON THE REPORTED INFORMATION AND THE EVENT ORIGINATING IN THE US, THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET.

    Additional Manufacturer Narrative · 0

    PLASTIC WRAP COULD BE A POTENTIAL CHOKING HAZARD, COULD BE INHALED OR SWALLOWED. BASED ON THE REPORTED INFORMATION AND THE EVENT ORIGINATING IN THE US, THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET COMPLAINT HISTORY REVIEWED. THERE HAVE BEEN NO COMPLAINTS FOR THIS ISSUE IN THE PREVIOUS 24 MONTHS. COMPLAINT IS NOT TRENDING BUT WILL CONTINUE TO BE MONITORED. RETURNED PRODUCT WAS HAND SORTED FOR "STICKINESS" AND FAILURE MODE WAS ATTEMPTED TO BE RECREATED. PRODUCT WAS PLACED IN OVEN AT 65C AND PLACED IN FRONT OF HEAT GUN TO MELT BAG AND RECREATE IMPROPER STORAGE CONDITIONS. PRODUCT WAS DEFORMED BUT WAS ABLE TO BE OPENED WITHOUT ISSUE. FAILURE MODE COULD NOT BE RECREATED AND THEREFORE COMPLAINT COULD NOT BE CONFIRMED. RISK(RA-47): R1: INFECTIOUS MATERIAL PRESENT ON DEVICE - UNABLE TO OPEN PACKAGE ASEPTICALLY - S=7, O=1, RPN=7. RPN < 25 THEREFORE RISK IS ACCEPTABLE.

    Description of Event or Problem · 0

    POUCH IS SHREDDING AND STICKING TO THE DEVICE WHEN OPENED. "ANESTHESIOLOGISTS WERE FORCED TO RAPIDLY REMOVE SMALL PIECES OF THE PLASTIC BAG WRAP FROM THE ORAL AIRWAY'S EXTERIOR SURFACE WHICH HAD SHREDDED LOOSE FROM THE REMAINDER OF THE PLASTIC BAG WRAP UPON OPENING. AS YOU CAN IMAGINE, THIS IS A NEAR EMERGENT SITUATION WHICH REQUIRES QUICK RESPONSE WHILE CONTINUOUSLY EVALUATING A PATIENT."

    Description of Event or Problem · 0

    POUCH IS SHREDDING AND STICKING TO THE DEVICE WHEN OPENED. "ANESTHESIOLOGISTS WERE FORCED TO RAPIDLY REMOVE SMALL PIECES OF THE PLASTIC BAG WRAP FROM THE ORAL AIRWAY'S EXTERIOR SURFACE WHICH HAD SHREDDED LOOSE FROM THE REMAINDER OF THE PLASTIC BAG WRAP UPON OPENING. AS YOU CAN IMAGINE, THIS IS A NEAR EMERGENT SITUATION WHICH REQUIRES QUICK RESPONSE WHILE CONTINUOUSLY EVALUATING A PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130681 SUNMED LLC GUEDEL PVC SZ4 CAE SUNMED LLC 1-1521-04

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other