BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B BRAUN MEDICAL, INC.

    MDR report key: 2288054 · Received September 28, 2011

    Report

    Report Number
    MW5022555
    Event Type
    Malfunction
    Date Received
    September 28, 2011
    Date of Event
    September 15, 2011
    Report Date
    September 27, 2011
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE BRAUN PERIFIX CONTINUOUS EPIDURAL ANESTHESIA TRAY WAS USED TO INSERT EPIDURAL INTO A LABORING PATIENT. PLACED WITHOUT INCIDENT BY ANESTHESIA AND INITIAL MEDICATION DOSE WAS GIVEN DIRECTLY INTO THE EPIDURAL SPACE. EPIDURAL CATH WAS THEN INSERTED AND GEMSTAR TUBING WAS ATTACHED. GEMSTAR PUMP ALERT WENT OFF STATING THERE WAS AN OCCLUSION. TROUBLESHOOTING DONE AND A NEW EPIDURAL HAD TO BE INSERTED. THE CATHETER WAS FOUND TO BE OCCLUDED WITH NO CONTINUOUS OPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B BRAUN MEDICAL, INC. EPIDURAL CATHETER CAZ B. BRAUN MEDICAL, INC. 61178871

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR