BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER, 2W SEC STD CH14

    MDR report key: 2972332 · Received February 15, 2013

    Report

    Report Number
    9611710-2013-00129
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    April 19, 2011
    Report Date
    May 5, 2011
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    KOD
    PMA / PMN Number
    K770256
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS IDENTIFIED DURING RETROSPECTIVE REVIEW ON COMPLAINTS FROM OUR FACILITY IN MALAYSIA. THIS IS RELATED TO (FDA AUDIT-OBSERVATION #5 FROM FEI (B)(4)). THE EVENT IS DEEMED SERIOUS AS IT REQUIRED MEDICAL INTERVENTION TO PREVENT A POSSIBLE SERIOUS OUTCOME. FROM A CLINICAL PERSPECTIVE, A CAUSAL RELATIONSHIP BETWEEN THE CATHETER AND THIS EVENT IS DEEMED RELATED BECAUSE IT WAS REPORTED THAT THE ONLY WAY TO REMOVE IT WAS TO PUNCTURE THE BALLOON THROUGH AN INVASIVE MEANS.

    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 (FDA AUDIT-OBSERVATION #5 FROM FEI (B)(4)). COMPLAINT RECEIVED AS FOLLOWS: "CUSTOMER'S COMPLAINT NO : (B)(4). DESCRIPTION OF COMPLAINT: IT WAS IMPOSSIBLE TO DEFLATE THE BALLOON. THEN THE SHAFT WAS CUT TWO TIMES, BUT THE BALLOON WAS NOT DEFLATED. GUIDE WIRE WAS INSERTED INFLATION LUMEN, BUT THE BALLOON WAS NOT DEFLATED. FINALLY THE BALLOON WAS TAPPED UNDER ECHO MEASUREMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69429 FOLEY CATHETER, 2W SEC STD CH14 UROLOGICAL CATHETER AND ACCESSORIES KOD UNOMEDICAL SDN BHD E210-14TN 402583R002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention