BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD SPINAL ANESTHESIA TRAY

    MDR report key: 5049230 · Received August 27, 2015

    Report

    Report Number
    MW5055872
    Event Type
    Other
    Date Received
    August 27, 2015
    Report Date
    August 27, 2015
    Manufacturer
    BD
    Product Code
    CAZ
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    MULTIPLE CERTIFIED REGISTERED NURSE ANESTHETISTS AT OUR HOSPITAL REPORTED CONCERNS ABOUT THE TIME TO ONSET AND EFFECTIVENESS THIS PRODUCT. THEY HAVE BEEN NOTICING A TREND OVER THE PAST 3-4 MONTHS OF DELAYED ONSET (UP TO AN HOUR WHEN THE ONSET IS EXPECTED WITHIN 10 MINUTES) AND DECREASED EFFECTIVENESS (INADEQUATE NUMBING AND ANALGESIA). IN MULTIPLE CASES, THE EFFECTIVENESS HAS BEEN SO DIMINISHED THAT THEY HAVE HAD TO USE GENERAL ANESTHESIA WHEN THE SPINAL ANESTHESIA DID NOT DO AS EXPECTED. THEY REPORT THAT THIS IS OCCURRING ON MULTIPLE PTS (BOTH ORTHOPEDIC AND CESAREAN SECTION PTS) OF VARYING AGES, SEX, WEIGHT, TYPE OF SURGERY, ETC. IN ADDITION TO THIS, THEY HAVE NOTICED AN INCREASED LENGTH OF EFFECTIVENESS, SO MUCH SO THAT IT HAS REQUIRED AN ADD'L 2-3 HOURS POST-OPERATIVE RECOVERY TIME IN ORDER FOR THE SPINAL ANESTHESIA TO WEAR OFF. THEY ARE UNABLE TO CORRELATE ANY SIMILARITIES AMONG THE PTS IN WHICH THESE ERRORS ARE OCCURRING. UNFORTUNATELY, THEY HAVE NOT BEEN TRACKING LOT NUMBERS, BUT DO STATE THAT THEY KNOW THERE HAVE BEEN AT LEAST 2 DIFFERENT LOTS WITH PROBLEMS. THEY WILL BEGIN TRACKING LOT NUMBERS FROM THIS TIME FORWARD. DATES OF USE: 3-4 MONTHS. DIAGNOSIS OR REASON FOR USE: SPINAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569777 BD SPINAL ANESTHESIA TRAY ANESTHESIA TRAYS CAZ BD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other