BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIFIX

    MDR report key: 2171536 · Received July 20, 2011

    Report

    Report Number
    2171536
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 20, 2011
    Manufacturer
    B. BRAUN
    Product Code
    BSO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) WAS IN THE PROCESS OF PLACING AN EPIDURAL. CLINICIAN ENCOUNTERED DIFFICULTY PLACING THE CATHETER. UPON INSPECTION, THERE WAS A KINK IN THE DEVICE. THE CATHETER WAS UNABLE TO PASS DUE TO THIS MANUFACTURING DEFECT. A NEW KIT WAS OBTAINED AND PLACED EASILY, WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIFIX ANESTHESIA CONDUCTION KIT, EPIDURAL CATHETER BSO B. BRAUN 332230 61154535

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR