BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIFIX CONTINUOUS EPIDURAL ANESTHESIA TRAY

    MDR report key: 3092194 · Received April 29, 2013

    Report

    Report Number
    MW5030017
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 29, 2013
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEFECTIVE GLASS SYRINGE IN B. BRAUN PERIFIX CONTINUOUS EPIDURAL ANESTHESIA TRAY. WHILE PREPARING TO DO AN EPIDURAL, STAFF OBSERVED THAT THE GLASS SYRINGE IN THE PERIFIX TRAY WAS DEFECTIVE. THE PLUNGER WILL NOT MOVE IN THE BARREL OF THE SYRINGE. A NEW TRAY WAS OPENED AND THE PROCEDURE COMPLICATED W/O INCIDENT. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184290 PERIFIX CONTINUOUS EPIDURAL ANESTHESIA TRAY EPIDURAL TRAY CAZ B. BRAUN MEDICAL INC. CE18HKCD 61287458

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR