BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD BORE EXTENSION SET WITH 0.2M FILTER

    MDR report key: 83132 · Received April 14, 1997

    Report

    Report Number
    MW1011131
    Event Type
    Injury
    Date Received
    April 14, 1997
    Date of Event
    April 11, 1997
    Report Date
    April 11, 1997
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT ON 5FU INFUSION. CATHETER WAS INADVERTENTLY CLAMPED AND LEAK DEVELOPED AT POINT WHERE TUBING ATTACHES TO FILTER. UPON FURTHER EXAM. USER FOUND THAT TUBING WAS NOT PROPERLY ATTACHED TO FILTER. LACK OF SECURITY CAUSED LEAK AND PREVENTED HIGH PRESSURE ALARM. LOW RATE (1MG/HR) PREVENTED SIGNIFICANT EXPOSURE OF PT TO DRUG. USER STATES THIS IS THE SECOND SUCH INCIDENCE WITH THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD BORE EXTENSION SET WITH 0.2M FILTER IV ADMINSTRATION SET FPA CHURCHILL MEDICAL SYSTEMS, INC. AMS-426 611 09

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| R