BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDEX LUBRICATH FOLEY CATHETER

    MDR report key: 1910427 · Received November 18, 2010

    Report

    Report Number
    1018233-2010-00113
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    August 19, 2010
    Report Date
    October 19, 2010
    Manufacturer
    C.R. BARD, INC.
    Product Code
    KOD
    PMA / PMN Number
    K910846
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RETURNED FOR EVAL. THE BALLOON HAD BURST WITH NO PIECES MISSING. THE DEVICE HISTORY RECORD WAS REVIEWED FINDING NOTHING THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED FAILURE. THE INSTRUCTIONS FOR USE CONTAINS A WARNING THAT STATES: "ON CATHETER, DO NOT USE OINTMENTS OR LUBRICANTS HAVING PETROLATUM BASE. THEY WILL DAMAGE LATEX AND MAY CAUSE THE BALLOON TO BURST." IT ALSO STATES THAT THE RECOMMENDED INFLATION CAPACITIES FOR THE 5CC BALLOON IS 10ML STERILE WATER AND THIS AMOUNT SHOULD NOT BE EXCEEDED. IT IS NOT KNOWN THE AMOUNT OF WATER USED TO INFLATE THE BALLOON. ADDITIONALLY, THE IFU STATES "SHOULD BALLOON RUPTURE OCCUR, CARE SHOULD BE TAKEN TO ASSURE THAT ALL BALLOON FRAGMENTS HAVE BEEN REMOVED FROM THE PT. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN INSERTED A SUPRAPUBIC CATHETER INTO THE PT. UPON PELVIC ULTRASOUND, THE BLADDER WAS EMPTY, BUT THE CATHETER COULD NOT BE VISUALIZED. THE NEXT DAY, THE NURSE NOTED URINE LEAKAGE FROM THE SUPRAPUBIC INSERTION AND A PORTION OF THE DEFLATED BALLOON WAS VISUALIZED IN THE INSERTION SITE. THE NURSE REMOVED THE CATHETER AND NOTICED THAT THE BALLOON HAD BURST, BUT NO PIECES WERE MISSING. THE PT WAS TAKEN TO SURGERY TO HAVE THE CATHETER REPLACED DUE TO AN IMMATURE STOMA TRACT. PT HAD AN UNSTABLE RESPIRATORY STATUS AND REQUIRED INTUBATION. PT WAS UNABLE TO BE EXTUBATED AND WAS SENT TO THE ICU FOR ONE NIGHT. PT WAS EXTUBATED ON (B)(6) 2010 AND WAS TRANSFERRED OUT OF ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARDEX LUBRICATH FOLEY CATHETER KOD C.R. BARD, INC. NA BL7041

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention