BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER, 2W HARD VALVE SIL CH08

    MDR report key: 2982610 · Received February 25, 2013

    Report

    Report Number
    9611710-2013-00167
    Event Type
    Malfunction
    Date Received
    February 25, 2013
    Date of Event
    October 19, 2011
    Report Date
    December 5, 2011
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    KOD
    PMA / PMN Number
    K841544
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INFO RECEIVED BY E-MAIL THAT THE PEDIATRIC PT WAS TAKEN TO THE OPERATING ROOM TO HAVE THE FOLEY REMOVED WHEN THE BALLOON WOULD NOT DEFLATE. A CYSTOSCOPE WAS PERFORMED TO AID REMOVAL OF THE BALLOON BY THE GUIDE WIRE. THE BALLOON WAS SUCCESSFULLY REMOVED AND AFTER THE PROCEDURE, THE PT TRANSFERRED TO THE ICU FOR OBSERVATION. THE PT WAS REPORTED TO BE STABLE POST PROCEDURE. THE EVENT IS DEEMED TO BE A SERIOUS ADVERSE EVENT DUE TO THE MEDICAL / SURGICAL INTERVENTION TO PUNCTURE THE BALLOON IN ORDER TO REMOVE IT FROM THE BLADDER, WHICH IF NOT REMOVED, COULD HAVE RESULTED IN SERIOUS HARM. FROM A CLINICAL PERSPECTIVE, A CAUSAL RELATIONSHIP BETWEEN THE CATHETER AND THIS EVENT IS DEEMED RELATED BECAUSE OTHER ATTEMPTS TO REMOVE IT FAILED AND IT WOULD ONLY COME OUT AFTER THE PROCEDURE. REPORTED TO THE FDA ON (B)(4) 2013.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW OF COMPLAINTS FROM OUR FACILITY IN (B)(6). THIS IS RELATED TO ((B)(4)). COMPLAINT RECEIVED AS FOLLOWS: "NO HARM OR INJURY TO PT. THE NON-DEFLATION IN USE WAS NOTED AT OPERATING ROOM. THE DEFECTIVE SAMPLE WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80650 FOLEY CATHETER, 2W HARD VALVE SIL CH08 UROLOGICAL CATHETER AND ACCESSORIES KOD UNOMEDICAL SDN BHD MM53120805 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention