BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUNGER HOLDER/ TRACK II

    MDR report key: 501229 · Received December 3, 2003

    Report

    Report Number
    1036813-2003-00090
    Event Type
    Malfunction
    Date Received
    December 3, 2003
    Date of Event
    November 3, 2003
    Report Date
    November 3, 2003
    Manufacturer
    MEDEX, INC.
    Product Code
    FIH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING IN-HOUSE TESTING, THE U-SPRING WAS FOUND DAMAGED IN SUCH AS WAY, THE PLUNGER HOLDER/TRACK II WOULD HAVE CAUSED THE SYRINGE PUMP TO FAIL TO ALERT "LOAD SYRINGE PLUNGER" OR "OCCLUSION" DEPENDING ON THE PUMP'S SOFTWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUNGER HOLDER/ TRACK II PLUNGER HOLDER/ TRACK II FIH MEDEX, INC. PLUNGER HOLDER/TRACK II NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA