BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET

    MDR report key: 4926468 · Received July 20, 2015

    Report

    Report Number
    8041145-2015-00050
    Event Type
    Injury
    Date Received
    July 20, 2015
    Date of Event
    August 30, 2012
    Report Date
    July 20, 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

    MANUFACTURER INVESTIGATION RESULT ON RETAINED SAMPLES, SAMPLE NOT RETURNED BY USER -DEVICE DISPOSED BY USER.

    Description of Event or Problem · 1

    DURINGE DIALYSIS TREATMENT, PATIENT COMPLAINED OF STOMACH PAIN, TECHNICIAN NOTICED KINKING OF BLOODLINES RESULTING IN HEMOLYSIS. MEDICAL INTERVENTION WAS REQUIRED. NO DETAILS WERE PROVIDED, NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469169 NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET BLOOD TUBING SET FJK NIPRO THAILAND CORPORATION LTD A201TR/768TR 11B09

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention