BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD MEDICAL DIVISION

    MDR report key: 271840 · Received March 30, 2000

    Report

    Report Number
    MW1018545
    Event Type
    Injury
    Date Received
    March 30, 2000
    Date of Event
    March 8, 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

    SIXTEEN DAYS AFTER INSERTION, BLADDER TRAINED FOR 12 HRS PLUS BY STAFF. 7:00 AM STAFF MEMBER ATTEMPTED TO REMOVE. TRIED MULTIPLE ATTEMPTS WITH SYRINGE AT PORT, NO RESULTS. CUT DIRECTLY BEHIND PORT AND DID NOT DRAIN AT ALL. TRIED AGAIN WITH SYRINGE AND REMAINDER OF PORT MULTIPLE TIMES. STILL UNSUCCESSFUL. PUT NEEDLE ON SYRINGE AND TRIED SLIDING ALONG PORT AS IT GOES INTO THE TUBE. 5 STAFF MEMBERS ATTEMPTED REMOVAL UNSUCCESSFULLY. CATHETER STILL DRAINING URINE, HAS NOT DEFLATED AT ALL. STAFF STOPPED ATTEMPT. PHYSICIAN CALLED. ADVISED UROLOGY CONSULT. ABOUT AN HR LATER RN REPEATED ATTEMPT. TOOK SYRINGE AND WENT INTO SIDE OF FOLEY INTO LUMEN OF WATER PORT. TRIED 4-5 TIMES THEN SUCCESSFULLY REMOVED CATHETER.

    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. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention