BEUDAMED
    FDA Adverse Event Other Summary report: N

    20 GA CLOSED SOFT TIP CATHETER

    MDR report key: 4189820 · Received October 15, 2014

    Report

    Report Number
    MW5038670
    Event Type
    Other
    Date Received
    October 15, 2014
    Report Date
    October 14, 2014
    Manufacturer
    B BRAUN
    Product Code
    CAZ
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    OPERATING ROOM REPORTED PROBLEM WITH EPIDURAL TRAY; TRAYS WITH SAME LOT NUMBER SEQUESTERED BY PHARMACY UNTIL FURTHER INVESTIGATION NARROWED DOWN THE PROBLEM; ASKED TODAY IF COMPANY NOTIFIED - CONTACTED B. BRAUN WITH TRAY LOT NUMBER (B)(6) 2014 AT 11:00, BUT CATHETER LOT WITH PROBLEM UNKNOWN; CONTACT INFORMATION FOR ANESTHESIA GIVEN TO B. BRAUN REPRESENTATIVE FOR MORE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652630 20 GA CLOSED SOFT TIP CATHETER EPIDURAL CATHETER CAZ B BRAUN
    652631 B. BRAUN CUSTOM SPINAL AND EPIDURAL ANESTHESIA TRAY B. BRAUN CUSTOM SPINAL AND EPIDURAL ANESTHESIA TRAY CAZ B BRAUN SESK 61376392

    Patients

    Seq Age Sex Outcome Treatment
    1