BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETER, BULLET TIP

    MDR report key: 20743 · Received March 27, 1995

    Report

    Report Number
    MW1005572
    Event Type
    Malfunction
    Date Received
    March 27, 1995
    Date of Event
    March 9, 1995
    Report Date
    March 9, 1995
    Manufacturer
    PHARMASEAL DIV. BAXTER HEALTHCARE CORP.
    Product Code
    BSO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EPIDURAL CATHETER WAS PLACED FOR LABOR ANALGESIA. UNABLE TO INJECT THROUGH CATHETER. INSPECTION REVEALED THAT THREE HOLES WERE MISSING. SUBSEQUENT CATHETER OF SAME LOT PLACED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIDURAL CATHETER, BULLET TIP Implant EPIDURAL CATHETER, BULLET TIP BSO PHARMASEAL DIV. BAXTER HEALTHCARE CORP. K3P336E

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other