BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDEX LUBRICATH FOLEY CATHETER

    MDR report key: 12107767 · Received July 2, 2021

    Report

    Report Number
    1018233-2021-03991
    Event Type
    Injury
    Date Received
    July 2, 2021
    Date of Event
    June 9, 2021
    Report Date
    June 16, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZC
    PMA / PMN Number
    K910846
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER WAS UNABLE TO REMOVE FOLEY CATHETER FOR TRIAL OF VOID DURING POST DEFLATION OF BALLOON. THE USER REMOVED 12ML VIA VALVE AND WAITED ABOUT 10 MINUTES WITH THE SYRINGE ATTACHED TO THE CATHETER VALVE TO SEE IF MORE WATER MIGHT BE DRAINED. THE USER WAS STILL UNABLE TO REMOVE THE FOLEY CATHETER AND FELT PLENTY OF RESISTANCE. PATIENT WAS NOT IN PAIN AND JUST EXPERIENCED URINARY URGENCY. THE DOCTOR TRIED TO REMOVE IT BY THEMSELF BUT WAS STILL NOT ABLE TO REMOVE IT. THE DOCTOR ATTEMPTED TO REMOVE THE CATHETER USING A GUIDE WIRE AND ALSO CUT THE TIP OF THE VALVE BUT STILL THE FOLEY CATHETER STUCK AT THE SAME POINT IN THE URETHRA. THE DOCTOR ARRANGED THE PATIENT TO WENT TO QUICK ACCESS COMPUTING (QXR) TO HAVE AN ULTRASOUND DONE AND NOTICED THAT SOME WATER WAS STILL IN THE BALLOON DUE TO FAULTY VALVE. THE PATIENT WAS UNDER ULTRASOUND GUIDANCE AND THE DOCTOR POPPED THE BALLOON BY FILLING IT WITH WATER. A FLEXIBLE CYSTOSCOPY WAS PERFORMED TO CHECK IF ANY BALLOON RESIDUE WAS LEFT BEHIND AND DOCTOR REMOVED A SIGNIFICANT SIZED PIECE OF RUPTURED BALLOON VIA SCOPE. PATIENT PASSED THE TRIAL OF VOID AND VOIDING WELL WITH MINIMAL POST VOID RESIDUALS (PVR) AND NO DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006196 BARDEX LUBRICATH FOLEY CATHETER FOLEY CATHETER EZC C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention