BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD MEDICAL DIVISION

    MDR report key: 271827 · Received March 30, 2000

    Report

    Report Number
    MW1018544
    Event Type
    Injury
    Date Received
    March 30, 2000
    Date of Event
    March 1, 2000
    Report Date
    March 13, 2000
    Manufacturer
    C.R. BARD, INC.
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INSERTED IN ER. TWO DAYS LATER STAFF WAS REMOVING FOLEY FOR DISCHARGE. WAS UNABLE TO ASPIRATE FLUID FROM FOLEY TO DEFLATE BALLOON. TOOK SCISSORS AND CUT SMALL AREA AT PORT TO SEE IF THIS WOULD ALLOW FLUID DRAINAGE AND DEFLATION OF BALLOON. DID NOT HAPPEN. CUT FURTHER UP TUBING, STILL UNABLE TO ASPIRATE FLUID AND DEFLATE BALLOON. TOOK SYRINGE WITH A NEEDLE AND INSERTED ABOUT 1" BELOW PT'S ANATOMY INTO SECTION OF TUBING. ABLE TO DEFLATE BALLOON AND REMOVE CATHETER INTACT, APPROX 1:30 PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD MEDICAL DIVISION 16 FRENCH FOLEY CATH - 5 CC KOD C.R. BARD, INC. 365716 PORT 9GG714

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention