BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD

    MDR report key: 1861373 · Received October 4, 2010

    Report

    Report Number
    MW5017689
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 4, 2010
    Manufacturer
    BD
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVING AN EPIDURAL FOR CHILD BIRTH. TIP OF THE EPIDURAL CATHETER BROKE OFF IN PT. TIP HAS BEEN LEFT IN PT AT THE ADVISE OF THE PHYSICIAN AND MEDICAL LITERATURE WHICH SUPPORTS NOT PERFORMING INVASION TREATMENT TO REMOVE. PT DELIVERED HEALTHY BABY BOY VIA NATURAL CHILDBIRTH. MOTHER AND BABY WERE DISCHARGED ON SCHEDULE (B)(6)2010 IN GOOD CONDITION. DATES OF USE: (B)(6)2010. DIAGNOSIS OR REASON FOR USE: CHILD BIRTH. EVENT ABATED AFTER USE: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD CONTINUOUS EPIDURAL TRAY CAZ BD 1T2673 GD874586

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR