BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIFIX CONTINUOUS EPIDURAL ANESTHESIA TRAY

    MDR report key: 2544747 · Received April 17, 2012

    Report

    Report Number
    MW5025125
    Event Type
    Malfunction
    Date Received
    April 17, 2012
    Date of Event
    April 15, 2012
    Report Date
    April 17, 2012
    Manufacturer
    B BRAUN MEDICAL, INC.
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PERIFIX CONTINUOUS EPIDURAL ANESTHESIA TRAY WITH PERIFIX 18 GA. X 3-1/2 IN. HUSTEAD EPIDURAL NEEDLE. EXP 2031-05, LOT #61193764, (B)(4), PRODUCT CODE (B)(4) MADE BY B BRAUN. NEEDLE USED EPIDURAL FOR PATIENT, NOT PATIENT. CRNA HAD INJECTED NEEDLE INTO PATIENT AND THEN WAS UNABLE TO INJECT MEDICATION. SECOND TRAY OPENED WITH SAME PROBLEM, DID NOT TOUCH PATIENT. THIRD TRAY OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIFIX CONTINUOUS EPIDURAL ANESTHESIA TRAY EPIDURAL TRAY CAZ B BRAUN MEDICAL, INC. 61193764

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR