BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETERS

    MDR report key: 3777700 · Received January 13, 2014

    Report

    Report Number
    9611710-2014-00015
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    December 14, 2013
    Report Date
    December 14, 2013
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    KOD
    PMA / PMN Number
    K841544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. IT IS REPORTED THAT THIS ISSUE OCCURRED WITH FOUR (4) PATIENTS WHO HAD TO BE PASSED ON TO THE UROLOGY WARD. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED VIA COMPLAINT FORM IS INDICATED AS FOLLOWS: THERE WAS A PROBLEM WITH DEFLATION OF THE BALLOON AFTER CATHERIZATION AND AFTERWARDS IT WAS NOT POSSIBLE TO REMOVE THE CATHETER FROM BLADDER. DEFLATION WAS NOT POSSIBLE USING EITHER SYRINGE OR SYRINGE WITH NEEDLE. THE BALLOONS WERE FILLED WITH PURE WATER (DISTILLED WATER) IN COMPLIANCE WITH THE INSTRUCTIONS FO RUSE (IFU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28005 FOLEY CATHETERS CATHETER, UROLOGICAL KOD UNOMEDICAL SDN BHD MM51121810 402496R001

    Patients

    Seq Age Sex Outcome Treatment
    1