BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSURETHRAL CATHETER

    MDR report key: 4929071 · Received July 21, 2015

    Report

    Report Number
    8040412-2015-00156
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Date of Event
    June 19, 2015
    Report Date
    June 23, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FGH
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD FOR LOT (14LE52) WAS REVIEWED AND NO ISSUE THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. ACTUAL SAMPLES WERE RETURNED FOR INVESTIGATION AND IT WAS OBSERVED THAT THE SAMPLE WAS INTACT AND WITHOUT ANY ISSUES. FURTHER EXAMINATION ON THE ACTUAL SAMPLE USING MAGNIFYING LENS (10X MAGNIFICATION) DID NOT REVEAL ANY SIGN OF ABRASION MARK OR SCRATCH TO SUGGEST ANY MANUFACTURING INADEQUACY. BASED ON OUR EXPERIENCE, IT IS VERY UNLIKELY THAT THE CATHETER COULD HAVE DETACHED WITHOUT ANY EXTERNAL FORCE OR EXTERNAL CONTACT. THE TUBE WAS MOLDED USING INJECTION MOLDING MACHINE WHERE TUBE WILL BE PHYSICALLY MOUNTED IN LIQUID SILICONE BEFORE IT GETS HEATED AND MOLDED INSIDE THE FUNNEL. WE DID NOT FIND ANY PROBLEM WITHIN THE PRODUCT, WHICH COULD HAVE CONTRIBUTED FROM MANUFACTURING PROCESSES. THE ACTUAL RETURNED SAMPLE WAS TESTED AND COMPLIED WITH REQUIRED STANDARDS. THEREFORE, WE COULD NOT CONFIRM THIS COMPLAINT.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE INDWELLING CATHETER WAS CUT AT THE LEVEL OF THE CONNECTION. THE BALLOON WAS DEFLATED AND THE CATHETER WAS REMOVED. THE REPORT DESCRIPTION DOES NOT CLEARLY DEFINE IF THE CATHETER WAS BROKEN OR IF THE DEVICE WAS UNABLE TO BE DEFLATED AND HAD TO BE CUT FOR REMOVAL. THE PATIENT'S CONDITION WAS REPORTED AS UNKNOWN.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE INDWELLING CATHETER WAS CUT AT THE LEVEL OF THE CONNECTION. THE BALLOON WAS DEFLATED AND THE CATHETER WAS REMOVED. THE REPORT DESCRIPTION DOES NOT CLEARLY DEFINE IF THE CATHETER WAS BROKEN OR IF THE DEVICE WAS UNABLE TO BE DEFLATED AND HAD TO BE CUT FOR REMOVAL. THE PATIENT'S CONDITION WAS REPORTED AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471726 TRANSURETHRAL CATHETER FOLEY CATHETER FGH TELEFLEX MEDICAL 14LE52

    Patients

    Seq Age Sex Outcome Treatment
    1