BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER, 2W HARD VALVE STD CH14

    MDR report key: 2993021 · Received March 1, 2013

    Report

    Report Number
    9611710-2013-00209
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    August 14, 2012
    Report Date
    August 14, 2012
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    KOD
    PMA / PMN Number
    K770256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW OF COMPLAINTS FROM OUR FACILITY IN (B)(6). THIS IS RELATED TO (FDA AUDIT-OBSERVATION #5 FROM (B)(4)). BASED ON AVAILABLE INFO, OUR MEDICAL DETERMINATION IS THAT THIS MALFUNCTION IS SERIOUS: BECAUSE SOMETIMES, SURGICAL INTERVENTION IS NEEDED TO REMOVE A CATHETER WHOSE BALLOON FAILS TO DEFLATE. IN THIS CASE, THE CATHETER BALLOON WAS EVENTUALLY DEFLATED BUT WITH MUCH DIFFICULTY. REPORTED TO THE FDA ON (B)(4) 2013.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED AS FOLLOWS: ¿THIS URINARY CATHETER AS WE HAD PROBLEMS WITH. SCRAMBLED IN THE FOLLOWING MANNER. WHEN WE WOULD PULL THE CATHETER COULD NOT CUFF TO EMPTY. IT WAS POSSIBLE TO INJECT WATER INTO IT BUT DO NOT ASPIRE ANYTHING OUT. THE SURGEONS THOUGHT TO TRY AND TO BLOW IT OR INJECT GASOLINE. I DID, HOWEVER, IN AND "ASPIERARADE" ML FOR ML AND WERE SLOWLY AND WITH GREAT FORCE TO THE LIQUID FROM THE CUFF. IT TOOK 15-20 MINUTES. WHEN I GOT THE CATHETER OUT, I SEE AN APPROX. 3 MM CRACK IN THE CUFF. SOME FORM OF INJURY "TRLIGTVIS" MADE SOME KIND OF VALVE MECHANISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89927 FOLEY CATHETER, 2W HARD VALVE STD CH14 UROLOGICAL CATHETER AND ACCESSORIES KOD UNOMEDICAL SDN BHD MM51161410 058666363

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention