BEUDAMED
    FDA Adverse Event Other Summary report: N

    COUNCIL TIP CATHETER

    MDR report key: 17594989 · Received August 21, 2023

    Report

    Report Number
    MW5144816
    Event Type
    Other
    Date Received
    August 21, 2023
    Date of Event
    August 18, 2023
    Report Date
    August 18, 2023
    Manufacturer
    BARD/C.R. BARD, INC.
    Product Code
    MJC
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SURGEON PERFORMED RIGHT URETEROSCOPY, HOLMIUM LASER LITHOTRIPSY, RIGHT STONE BASKET EXTRACTION, RIGHT URETERAL STENT PLACEMENT AND COMPLEX FOLEY CATHETER PLACEMENT FOR A LARGE RIGHT URETERAL STONE. THE PRODUCT MALFUNCTION WAS DURING THE COMPLEX FOLEY CATHETER PLACEMENT. THE SURGEON REQUESTED A 20 FR COUNCIL TIP CATHETER WHICH WAS SUPPLIED. UPON PLACING THE BALLOON FAILED AND UPON REMOVING FROM PATIENT IT WAS DETERMINED THAT IT HAD A VERY TINY PIN HOLE IN IT. A SECOND 20 FR COUNCIL TIP WAS SUPPLIED AND WHEN PLACED THE BALLOON WOULD NOT INFLATE. I PERSONALLY LOOKED AT PACKAGING AND NOTICED BOTH WERE FROM SAME LOT SO I RETRIEVED A THIRD 20 FR COUNCIL TIP CATHETER FOR SURGEON FROM A DIFFERENT LOT WHICH WAS PLACED AND BALLOON INFLATED PROPERLY. ALL 20 FR COUNCIL TIP CATHETERS IN THE LOT THAT HAD ISSUE WERE PULLED FROM SHELF. REFERENCE REPORT: MW5144815.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035634 COUNCIL TIP CATHETER CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES MJC BARD/C.R. BARD, INC. 0196SI20 NGHS0500

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown