BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET

    MDR report key: 4929695 · Received July 21, 2015

    Report

    Report Number
    8041145-2015-00051
    Event Type
    Injury
    Date Received
    July 21, 2015
    Date of Event
    November 29, 2012
    Report Date
    July 21, 2015
    Manufacturer
    NIPRO THAILAND CORPORATION LTD
    Product Code
    FJK
    PMA / PMN Number
    K072024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS ON RETAINED SAMPLES ONLY. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    DISCONNECTION OF THE VENOUS LINE IN THE BLOOD TUBING SET, CAUSING SIGNIFICANT BLOOD LOSS. NO FURTHER INFORMATION WAS PROVIDED ON DETAILS OR PATIENT OUTCOME

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470893 NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET BLOOD TUBING SET FJK NIPRO THAILAND CORPORATION LTD A205TR/V773TR 12A23

    Patients

    Seq Age Sex Outcome Treatment
    1 Other