BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSURETHRAL CATHETER

    MDR report key: 4929649 · Received July 21, 2015

    Report

    Report Number
    8040412-2015-00157
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 25, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FGH
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(B)(4). THE DEVICE SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD FOR LOT 14KE45 WAS REVIEWED AND NO ISSUE THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. THE RETURNED SAMPLE WAS 100% VISUALLY INSPECTED USING MAGNIFICATION LENS. THE SAMPLE APPEARED TO BE IN A GOOD CONDITION EXCEPT THAT THE BALLOON WAS SPLIT. CLOSER EXAMINATION ON THE SPLIT BALLOON AREA UNDER DINO-LITE REVEALED SCRATCH MARKS NEAR THE TEAR REGION. ANY DEFECTIVE RAW BALLOON WILL BE CULLED OUT BEFORE BEING SENT TO THE NEXT PROCESS. AFTER ASSEMBLY, ALL FOLEY CATHETERS ARE THEN SUBJECTED TO LEAK TEST. PRODUCTS THAT PASS THIS TEST WILL BE SUBJECTED TO THE NEXT PROCESS. BASED ON THE INVESTIGATION CONDUCTED ON THE ACTUAL SAMPLE, IT IS BELIEVED THAT THE SCRATCH MARKS FOUND NEAR THE SPLIT AREA HAD INITIATED THE TEAR, DUE TO CONTACT WITH SHARP OR POINTED OBJECT. THEREFORE, WE COULD NOT CONFIRM THIS COMPLAINT, AS STATED.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE NURSE INSERTED THE CATHETER, WHEN BALLOON WAS INFLATED, IT SNAPPED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE NURSE INSERTED THE CATHETER, WHEN BALLOON WAS INFLATED, IT SNAPPED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470849 TRANSURETHRAL CATHETER FOLEY CATHETER FGH TELEFLEX MEDICAL 14KE45

    Patients

    Seq Age Sex Outcome Treatment
    1