BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL (SDD) 25G W/DRUGS

    MDR report key: 10945533 · Received December 4, 2020

    Report

    Report Number
    10945533
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Date of Event
    November 10, 2020
    Report Date
    November 18, 2020
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TWO PATIENTS ON THE SAME DAY USING THE SAME SPINAL KITS DID NOT OBTAIN ADEQUATE ANESTHESIA. PREVIOUS FAILED SPINAL WAS APPROXIMATELY 2 MONTHS AGO. BOTH SPINAL PROCEDURES WERE UNEVENTFUL, HOWEVER BOTH HAD INSUFFICIENT ANESTHESIA AT 30 MIN POST-BLOCK (WEAK BUT ABLE TO MOVE FEET, INCOMPLETE SENSORY BLOCK). EACH CASE REQUIRED A REPEAT SPINAL WHICH CARRIES AN INCREASED RISK OF HIGH SPINAL + DELAYS CASES. WE WERE USING "NEW" SPINAL KITS FROM A DIFFERENT MANUFACTURER. THESE KITS INCLUDE 0.75% BUPIVACAINE WITH DEXTROSE USED FOR SPINAL ANESTHETIC. BOTH FAILED SPINALS USED THE BUPIVACAINE FROM THE KIT. BUPIVACAINE FROM THE ANESTHESIA CART DURING THE SECOND SPINALS FOR EACH PATIENT AND THE BOTH WORKED GREAT. PER MD, "POSSIBLY A BAD BATCH OF BUPIVICAINE IN THESE NEW SPINAL KITS. FAILED SPINALS ARE INFREQUENT AND SEEMS LIKE TOO MUCH OF A COINCIDENCE TO HAVE IT HAPPEN BACK-TO-BACK LIKE THAT WITH A NEW SPINAL KIT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411656 SPINAL (SDD) 25G W/DRUGS ANESTHESIA CONDUCTION KIT CAZ 4030937

    Patients

    Seq Age Sex Outcome Treatment
    1 10220 DA