BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESY-TAP LEG BG W/18 PVC TUBING

    MDR report key: 17596064 · Received August 22, 2023

    Report

    Report Number
    3011137372-2023-00214
    Event Type
    Malfunction
    Date Received
    August 22, 2023
    Date of Event
    August 4, 2023
    Report Date
    August 7, 2023
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FAQ
    UDI-DI
    14026704645753
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED AS NO LOT NUMBER WAS PROVIDED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "PATIENT SAID HE GOT BLOOD CLOTS WHILE USING LEG BAGS AND THEY BROKE. PATIENT SAID THE BLOOD CLOT GOT STUCK AT TOP HOSE ATTACHED TO LEG BAG AND HE USED GARDEN WIRE TO TRY AND GET IT UNSTUCK, AND THE HOSE BROKE. PATIENT STATES BOTTOM NOZZLE TOO TIGHT TO OPEN. NO MEDICAL INTERVENTION WAS REPORTED". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED. SEE ASSOCIATED MDRS #3011137372-2023-00211 AND 3011137372-2023-00212.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310493 ESY-TAP LEG BG W/18 PVC TUBING ESY-TAP LEG BG W/18 PVC TUBING FAQ TELEFLEX MEDICAL 14026704645753

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown