BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER, 2W TIEMANN SEC CH16

    MDR report key: 2935071 · Received January 28, 2013

    Report

    Report Number
    9611710-2013-00027
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    October 19, 2011
    Report Date
    October 31, 2012
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    KOD
    PMA / PMN Number
    K841544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTION REVIEW ON COMPLAINTS FROM OUR FACILITY IN (B)(4). THIS IS RELATED TO (FDA AUDIT-OBSERVATION #7 FROM (B)(4)). BASED ON AVAILABLE INFO, 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. REPORT TO FDA ON JANUARY 26, 2013.

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING CREATED AS PART OF A FURTHER CORRECTIVE ACTION, RETROSPECTIVE REVIEW FOR 'PRIVATE LABEL' PRODUCT (FDA AUDIT-OBSERVATION #7). THIS COMPLAINT WAS RECEIVED BY (B)(4) ON (B)(4) 2012 FROM (B)(6) FOR PRODUCT 2 WAY TIEMANC SEC FOLEY CATHETER SIZE 16X10. CUSTOMER COMPLAINING:" " NON DEFLATION. AT THE PRIOR TEST BEFORE USE, IT WAS IMPOSSIBLE TO INFLATE AND DEFLATE THE BALLOON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37960 FOLEY CATHETER, 2W TIEMANN SEC CH16 UROLOGICAL CATHETER AND ACCESSORIES KOD UNOMEDICAL SDN BHD T210-16TN 405161R001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention