BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSATOR ARTERIAL BLOOD SAMPLING KIT

    MDR report key: 444485 · Received February 21, 2003

    Report

    Report Number
    1217052-2003-00020
    Event Type
    Malfunction
    Date Received
    February 21, 2003
    Date of Event
    January 1, 2003
    Report Date
    January 22, 2003
    Manufacturer
    PORTEX, INC.
    Product Code
    GJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AFTER A BLOOD DRAW, A STAFF MEMBER PLACED A FILTER-PRO UNIT ON TOP OF THE SYRINGE. WHILE EXPELLING AIR FROM SYRINGE, THE FILTER-PRO ALLEGEDLY BLEW OFF RESULTING IN POTENTIAL BLOOD EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSATOR ARTERIAL BLOOD SAMPLING KIT TRAY, BLOOD COLLECTION GJE PORTEX, INC. NA K142473

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO