BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTERIAL POST W LUER LOCKS DW 480

    MDR report key: 38030 · Received September 10, 1996

    Report

    Report Number
    8030665-1996-00271
    Event Type
    Injury
    Date Received
    September 10, 1996
    Report Date
    August 23, 1996
    Manufacturer
    NMC MPD
    Product Code
    FJK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ARTICLE ALLEGED: COMPLAINT OF BACK PAIN, NAUSEA, VOMNITING, PANCREATITIS WERE ESPRESSED BY PT AFTER 4 HOURS OF DIALYSIS TREATMENT. ALTHOUGH NOT DIRECTLY OBSERVED, IT WAS SPECULATED THAT HEMOLYTIC REACTIONS WERE CAUSED BY KINKED BLOOD LINES. COMPLAINTS OF THIS NATURE WERE INVESTIGATED UNDER FIR #93015. PRODUCT #0392035 UNDER SAME COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTERIAL POST W LUER LOCKS DW 480 * FJK NMC MPD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization