BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD

    MDR report key: 1081169 · Received July 24, 2008

    Report

    Report Number
    MW5007780
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    July 17, 2008
    Report Date
    April 24, 2008
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON REMOVAL OF URINARY CATHETER THAT WAS RECENTLY PLACED, RESISTANCE WAS MET AND CATHETER APPEARED "STUCK". MD USED MODERATE SEDATION, AND CATH WAS REMOVED INTACT. UPON REMOVAL, THE CATHETER APPEARED TO HAVE A HARD RING AT THE END OF BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD SILICONE SILVER COATED CATHETER 14FR 5A BALLOON KOD HCR 12159

    Patients

    Seq Age Sex Outcome Treatment
    1 Other