BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    100%SILICONE 2WAY 5CC 18F

    MDR report key: 4899034 · Received July 8, 2015

    Report

    Report Number
    8040412-2015-00140
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Date of Event
    June 4, 2015
    Report Date
    June 9, 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 LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DHR REVIEW COULD NOT BE CONDUCTED. THERE WAS NO COMPLAINT DEVICE RETURNED FOR INVESTIGATION; THEREFORE, NO PHYSICAL ASSESSMENT COULD BE CONDUCTED. LEAK 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. THEREFORE THIS 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 DEFLATED AND THE CATHETER CAME OUT OF THE PATIENT. A NEW CATHETER WAS INSERTED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE BALLOON DEFLATED AND THE CATHETER CAME OUT OF THE PATIENT. A NEW CATHETER WAS INSERTED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442660 100%SILICONE 2WAY 5CC 18F FOLEY CATHETER FGH TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1