BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER, 2W STD SLC CH14

    MDR report key: 2935117 · Received January 28, 2013

    Report

    Report Number
    9611710-2013-00030
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    November 10, 2011
    Report Date
    November 10, 2011
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    KOD
    PMA / PMN Number
    K944007
    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 (B)(4). THIS IS RELATED TO (FDA AUDIT-OBSERVATION (B)(4)). THE EVENT IS DEEMED SERIOUS AS IT REQUIRED MEDICAL / SURGICAL INTERVENTION TO REMOVE THE CATHETER WHOSE BALLOON HAD FAILED TO DEFLATE. IF FORCIBLY REMOVED WITH THE BALLOON FULLY INFLATED, THIS COULD HAVE RESULTED IN SERIOUS HARM TO THE PT. REPORT TO FDA ON (B)(4) 2013.

    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 (B)(4)). THIS COMPLAINT WAS RECEIVED BY (B)(6) ON (B)(6) 2011 FROM (B)(4) FOR PRODUCT 2 WAY STANDARD SLC FOLEY CATHETER SIZE 14X10. CUSTOMER COMPLAINING:" IMPOSSIBLE TO DEFLATE THE BALLOON. AFTER 2 WEEKS FROM THE CATHETER INDWELLED. IT WAS IMPOSSIBLE TO DEFLATE THE BALLOON OF CATHETER INDWELLED IN THE PT. THEN NEEDLE WAS USED TO RUPTURE THE BALLOON FROM OUTSIDE BODY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38199 FOLEY CATHETER, 2W STD SLC CH14 UROLOGICAL CATHETER AND ACCESSORIES KOD UNOMEDICAL SDN BHD HY210-14JN 401504R001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention