BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT

    MDR report key: 387360 · Received April 5, 2002

    Report

    Report Number
    MW1024639
    Event Type
    Malfunction
    Date Received
    April 5, 2002
    Date of Event
    February 11, 2002
    Report Date
    March 5, 2002
    Manufacturer
    ABBOTT LABS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    FILTER ON TUBING WAS LEAKING AROUND IT/COMING APART. CONTAINED CHEMOTHERAPY. REPORTED BY HOME HEALTH ON 03/2002. REPORTED TO HOME HEALTH BY PT ON 02/2002. PT REINSERTED TUBING TO AIR FILTER AND APPLIED SUPERGLUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AIMS PLUS TUBING FPA ABBOTT LABS * 82073 4W

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR