BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIATRIC CATH KIT 8FR

    MDR report key: 17564236 · Received August 15, 2023

    Report

    Report Number
    MW5144648
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Date of Event
    August 9, 2023
    Report Date
    August 11, 2023
    Manufacturer
    C. R. BARD
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PHYSICIAN ORDERED A CATHETERIZATION TO BE DONE ON THE 10 MONTHS OLD PATIENT. PREPPED THE AREA, INSERTED THE CATH, THE CATH BROKE AWAY FROM THE PLASTIC CUP THAT CATCHES THE URINE. NO HARM TO PATIENT. SEVERAL OTHER CATH KITS WITH THE SAME LOT NUMBER WERE OPENED AND WERE NOTED TO HAVE THE SAME CONCERN. LOT# NGGV0947 EXPIRATION: 01/31/2025.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON OCTOBER 12, 20023 TO CHANGE MANUFACTURER'S NAME FOR REPORT NUMBER MW5144648.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1759438 PEDIATRIC CATH KIT 8FR CATHETER, UROLOGICAL KOD C. R. BARD NGGV0947

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Female Other