BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    100% SIL TIEMANN 2WAY 5CC

    MDR report key: 4912588 · Received July 14, 2015

    Report

    Report Number
    8040412-2015-00147
    Event Type
    Malfunction
    Date Received
    July 14, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 16, 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 HISTORY RECORD WAS REVIEWED AND NO ISSUE THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. THERE WAS NO COMPLAINT DEVICE RETURNED FOR INVESTIGATION. THEREFORE , NO PHYSICAL ASSESSMENT COULD BE CONDUCTED. BURST BALLOON COULD BE DUE TO VARIOUS REASONS. HOWEVER, IN THE ABSENCE OF RETURNED SAMPLE AND LIMITED INFORMATION AVAILABLE ON THIS COMPLAINT, FURTHER INVESTIGATION COULD NOT BE CONDUCTED AND; THEREFORE COMPLAINT IS NOT CONFIRMED.

    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 BALLOON BURST AND THE CATHETER WAS FOUND IN THE PATIENT'S BED WITH NO BALLOON SO THE BALLOON BURST INSIDE THE PATIENT'S BLADDER. HOWEVER THE NURSE CONFIRMED THAT THE PATIENT EVACUATED THE BALLOON PIECES THROUGH NATURAL MEANS. STERILE WATER 10 CC WAS USED TO INFLATE THE BALLOON. A LARGER SIZE CATHETER, SIZE 16, WAS INSERTED IN THE PATIENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE BALLOON BURST AND THE CATHETER WAS FOUND IN THE PATIENT'S BED WITH NO BALLOON SO THE BALLOON BURST INSIDE THE PATIENT'S BLADDER. HOWEVER THE NURSE CONFIRMED THAT THE PATIENT EVACUATED THE BALLOON PIECES THROUGH NATURAL MEANS. STERILE WATER 10 CC WAS USED TO INFLATE THE BALLOON. A LARGER SIZE CATHETER, SIZE 16, WAS INSERTED IN THE PATIENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457520 100% SIL TIEMANN 2WAY 5CC FOLEY CATHETER FGH TELEFLEX MEDICAL 13GE31

    Patients

    Seq Age Sex Outcome Treatment
    1