BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER, 2W STD SEC CH16

    MDR report key: 2932435 · Received January 24, 2013

    Report

    Report Number
    9611710-2013-00016
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    August 22, 2011
    Report Date
    September 19, 2011
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    KOD
    PMA / PMN Number
    K770256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW ON COMPLAINTS FROM OUR FACILITY IN MALAYSIA. THIS IS RELATED TO (FDA AUDIT-OBSERVATION #7 FROM FEI (B)(4)). BASED ON AVAILABLE INFORMATION, OUR MEDICAL DETERMINATION IS THAT THIS MALFUNCTION IS SERIOUS: BECAUSE SOMETIMES, A SURGICAL INTERVENTION IS NEEDED TO REMOVE A CATHETER WHOSE BALLOON FAILS TO DEFLATE.

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING CREATED AS PART OF A FURTHER CORRECTION ACTION, RETROSPECTIVE REVIEW FOR 'PRIVATE LABEL' PRODUCT (FDA AUDIT-OBSERVATION #7). THIS COMPLAINT WAS RECEIVED BY (B)(6) ON 19TH SEP 2011 FROM TORAY MEDICAL CO LTD FOR PRODUCT 2 WAY STANDARD SEC FOLEY CATHETER. CUSTOMER COMPLAINING:" IMPOSSIBLE TO DEFLATE THE BALLOON. IT WAS IMPOSSIBLE TO DEFLATE THE BALLOON OF CATHETER INDWELLED IN THE PATIENT. THE SHAFT WAS CUT AND THE BALLOON WAS DEFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35266 FOLEY CATHETER, 2W STD SEC CH16 UROLOGICAL CATHETER AND ACCESSORIES KOD UNOMEDICAL SDN BHD E210-16TN 401504R001

    Patients

    Seq Age Sex Outcome Treatment
    1