BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT PAIN MGR II

    MDR report key: 478420 · Received August 15, 2003

    Report

    Report Number
    478420
    Event Type
    Malfunction
    Date Received
    August 15, 2003
    Date of Event
    August 3, 2003
    Report Date
    August 14, 2003
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN CHANGING PCA VIAL, RN REMOVED EMPTY VIAL AND ATTACHED NEW VIAL TO PLASTIC PLUNGER. ATTEMPTED TO REMOVE IV TUBING FROM OPPOSITE END OF PLUNGER TO EXPEL AIR FROM VIAL, BUT PLASTIC TUBING ATTACHMENT BROKE. TUBING WAS THEN COMPLETELY REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT PAIN MGR II PCA IV TUBING FPA ABBOTT LABORATORIES 4818 *+H376048180101A*

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other