BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER

    MDR report key: 8881240 · Received August 9, 2019

    Report

    Report Number
    1018233-2019-04644
    Event Type
    Malfunction
    Date Received
    August 9, 2019
    Date of Event
    July 16, 2019
    Report Date
    August 9, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    MJC
    UDI-DI
    00801741039843
    PMA / PMN Number
    K070582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS CONFIRMED AS CAUSE UNKNOWN. A VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED (WITHOUT ORIGINAL PACKAGING), TEMPERATURE SENSING SILICONE FOLEY CATHETER. VISUAL INSPECTION OF THE SAMPLE NOTED NO OBVIOUS VISIBLE DEFECTS. THE CATHETER BALLOON WAS ATTEMPTED TO INFLATE WITH 10 ML METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML DISTILLED WATER) AND IMMEDIATELY LEAKED FROM A PINHOLE IN BALLOON SURFACE OF SIZE (0.012") WITH NO MISSING PIECES. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE "TOOLING DAMAGED (CORE PINS)". THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "[WARNINGS] METHOD FOR USE: DO NOT INFLATE THE BALLOON IN THE URETHRA. [THE URETHRA MAY BE INJURED.] DO NOT PULL THE CATHETER HARD. [THE BLADDER/URETHRA MAY BE INJURED.] APPLICABLE PATIENTS: PATIENTS WITH DELIRIUM WHO MIGHT PULL OUT CATHETER [WHEN PATIENT TUGS AT CATHETER UNCONSCIOUSLY, THE BLADDER AND URETHRA MAY BE DAMAGED.]"

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER FELL OUT OF THE PATIENT ON THE DAY OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674404 BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER FOLEY CATHETER (SILICONE) MJC C.R. BARD, INC. (COVINGTON) -1018233 119314 NGCX0636 00801741039843

    Patients

    Seq Age Sex Outcome Treatment
    1