BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAL A/V BLOOD LINE SET 6MM

    MDR report key: 19942 · Received August 1, 1994

    Report

    Report Number
    2243621-1994-01068
    Event Type
    Injury
    Date Received
    August 1, 1994
    Date of Event
    July 21, 1994
    Report Date
    July 25, 1994
    Manufacturer
    DIAL MEDICAL
    Product Code
    KOC
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY REPORTED THAT THE A/V BLOODLINE WAS "MALFORMED" ALLOWING AIR TO ENTER SYSTEM. HEMODIALYSIS TREATMENT DISCONTINUED, LINES CHANGED, TRREATMENT RESUMED. DENIES PT INJURY. PT DISCHARGED TO HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAL A/V BLOOD LINE SET 6MM HEMODIALYSIS BLOOD LINE KOC DIAL MEDICAL A4C01

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention