BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSURETHRAL CATHETER

    MDR report key: 4929286 · Received July 21, 2015

    Report

    Report Number
    8040412-2015-00161
    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

    (B)(4). THE DEVICE HISTORY RECORD FOR LOT 14LE49 WAS REVIEWED AND NO ISSUE THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. VISUAL EXAMINATION WAS CONDUCTED ON THE RETURNED CATHETER AND IT WAS OBSERVED THAT THE BALLOON HAD SPLIT. THE RETURNED SAMPLE WAS 100% VISUALLY INSPECTED USING MAGNIFICATION LENS. THE SAMPLE REVEALED SCRATCH MARKS ALONG THE SPLIT AREA. CATHETER WITH DEFECTIVE BALLOON WILL BE CULLED OUT BEFORE BEING SENT TO THE NEXT PROCESS AND SUBJECTED TO A LEAK TEST. CATHETERS WITH DEFECTIVE BALLOON WILL BE CULLED DURING THIS PROCESS. BASED ON THE INVESTIGATION CONDUCTED, SPLIT BALLOON WOULD LIKELY OCCUR DUE TO BALLOON BEING SUBJECTED TO THE SHARP OBJECT WHICH WOULD CAUSE THE SPLIT BALLOON. THEREFORE, WE COULD NOT CONFIRM THIS COMPLAINT, AS STATED.

    Additional Manufacturer Narrative · 1

    (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.

    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
    472173 TRANSURETHRAL CATHETER FOLEY CATHETER FGH TELEFLEX MEDICAL 14LE49

    Patients

    Seq Age Sex Outcome Treatment
    1