BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT LABORATORIES

    MDR report key: 99938 · Received June 11, 1997

    Report

    Report Number
    99938
    Event Type
    Malfunction
    Date Received
    June 11, 1997
    Date of Event
    May 1, 1997
    Report Date
    June 10, 1997
    Manufacturer
    ABBOTT LAB
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    Y-TYPE BLOOD SET WITH PUMP; BEVELED END OF ONE SIDE OF "Y' CONFIGURATION BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT LABORATORIES Y-TYPE BLOOD SET WITH PUMP BRZ ABBOTT LAB 1873 08 7524-R11-5/95

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other