BEUDAMED
    FDA Adverse Event Other Summary report: N

    CIRC ADLT ANES-SM-MRMC-RC-LF

    MDR report key: 868102 · Received June 19, 2007

    Report

    Report Number
    1417592-2007-00028
    Event Type
    Other
    Date Received
    June 19, 2007
    Report Date
    June 6, 2007
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS RECEIVED AND REVIEWED. THE ISSUES ARE CONFIRMED. THE RUBBER BUSHING AND THE BAG ARE NOT TOGETHER, THEY ARE ACTUALLY SEPARATED (CAME APART). ISSUED A SUPPLIER ALERT TO THE MANUFACTURER WITH THE SCAR NUMBER. ALSO FORWARDED THE SAMPLE TO THEM FOR FURTHER ANALYSIS. THE SUPPLIER REVIEWED THE SAMPLE AND REVIEWED THEIR PROCESSING PROCEDURES FOR ASSEMBLING AND INSPECTING BUSHED BAGS. THEY HAVE IMPLEMENTED NEW PROCEDURES TO INCLUDE THE FOLLOWING: BETTER DEFINE THE VISUAL INSPECTION OF A BAG AND BUSHING PRIOR TO ASSEMBLY. THIS WILL INCLUDE BOTH A VISUAL FOR COSMETIC DEFECTS AND THOSE TO WHICH THE PERFORMANCE OF THE PRODUCT WILL LIKELY BE AFFECTED. BETTER DEFINE THE VISUAL INSPECTION OF A BUSHED BAG AFTER ASSEMBLY AND PRIOR TO TESTING. THIS WILL INCLUDE INSPECTIONS FOCUSED ON THE ASSEMBLY AND ITS IMPACT ON THE USABILITY OF THE ASSEMBLED PRODUCT. PROVIDE RETRAINING OF THE ASSEMBLY PERSONNEL. CONDUCT A FOLLOW UP AUDIT OF THE FACILITY.

    Description of Event or Problem · 1

    A MALE PATIENT HAD JUST BEEN EXTUBATED POST TONSILLECTOMY. IT WAS REPORTED THAT HE HAD A PARTIAL LARYNGOSPASM AND THE CRNA WAS USING MASK VENTILATION WITH POSITIVE PRESSURE TO TRY TO BREAK THE SPASM. SPASM WAS SLOWLY RESOLVING (PATIENT'S VITAL SIGNS WERE ACCEPTABLE) WHEN BREATHING BAG REPORTEDLY CAME APART AT THE NECK. ANOTHER BAG WAS USED AND IT WAS USED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRC ADLT ANES-SM-MRMC-RC-LF NONE CAI MEDLINE INDUSTRIES, INC. DYNJAA9903 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention