BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIFIX

    MDR report key: 1822446 · Received August 11, 2010

    Report

    Report Number
    1822446
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 11, 2010
    Manufacturer
    B. BRAUN MEDICAL INC
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    FOLLOWING INSERTION OF THE EPIDURAL CATHETER, THE PHYSICIAN WAS INJECTING THE TEST DOSE OF MEDICATION AND NOTICED THE MEDICATION COMING OUT OF A HOLE IN THE CATHETER. THE CATHETER WAS CUT OFF BELOW THE SITE OF THE DEFECT AND THE APPROPRIATE ADAPTER WAS APPLIED SO THAT THE REMAINING CATHETER WAS STILL FUNCTIONING. THE DECISION TO CUT THE TUBING WAS MADE AS THE CATHETER WAS STILL WORKING AND THE PATIENT WAS RECEIVING ADEQUATE PAIN RELIEF. THE PATIENT ALSO HAD A HISTORY OF MULTIPLE BACK SURGERIES RESULTING IN PLATES AND RODS IN THE BACK. THERE WAS NO INJURY TO THE PATIENT. THE FACILITY WILL CONTACT THE MANUFACTURER. AT THIS POINT IN TIME, THERE HAVE BEEN NO ADDITIONAL DEFECTIVE PRODUCTS FOUND IN THIS PARTICULAR LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIFIX ANESTHESIA CONDUCTION KIT CAZ B. BRAUN MEDICAL INC SPRINGWOUND 61098298

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR