BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESY-TAP LEG BG W/18 PVC TUBING

    MDR report key: 12100853 · Received July 1, 2021

    Report

    Report Number
    3011137372-2021-00165
    Event Type
    Malfunction
    Date Received
    July 1, 2021
    Date of Event
    June 17, 2021
    Report Date
    June 18, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FAQ
    UDI-DI
    14026704645753
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#: (B)(4). NO DEVICE HISTORY RECORD (DHR) WAS CONDUCTED DUE TO NO LOT# PROVIDED, THEREFORE; PRODUCT CAN'T BE TRACED. NO SAMPLE IS AVAILABLE FOR THE MANUFACTURER TO EVALUATE. OUR PRODUCTS HAVE BEEN TESTED FOR BIOCOMPATIBILITY. OTHER CUSTOMERS HAVE NO COMPLAINTS IN THIS RESPECT. THIS MAY BE AN EXCEPTIONAL CASE. THE QUALITY DEPARTMENT WILL CONTINUE TO FOLLOW UP. THE CUSTOMER MAY USE IT FOR A LONG TIME OR HAVE SENSITIVE SKIN. THE QUALITY DEPARTMENT WILL CONTINUE TO FOLLOW UP.

    Description of Event or Problem · 0

    SHE DOES NOT LIKE THE BAGS WE SENT BECAUSE THEY CAUSE AN INFECTION ON HER SKIN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    SHE DOES NOT LIKE THE BAGS WE SENT BECAUSE THEY CAUSE AN INFECTION ON HER SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001766 ESY-TAP LEG BG W/18 PVC TUBING ESY-TAP LEG BG W/18 PVC TUBING FAQ TELEFLEX MEDICAL IPN054586 UNKNOWN 14026704645753

    Patients

    Seq Age Sex Outcome Treatment
    1