BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED STREAM

    MDR report key: 419042 · Received September 25, 2002

    Report

    Report Number
    MW1026266
    Event Type
    Malfunction
    Date Received
    September 25, 2002
    Date of Event
    September 18, 2002
    Report Date
    September 19, 2002
    Manufacturer
    MEDICAL SPECIALTIES DISTRIBUTORS INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EXTENSION SET TUBING BROKE (STRAIGHT ACROSS) DISTAL TO THE CLAMP. BLEEDING STARTED. PT CLAMPED AND CALLED HOMEHEALTH AGENCY. NURSE MADE VISIT AND CHANGED. THERAPY RESUMED, PATENCY RESUMED AFTER CHANGING EXTENSION SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED STREAM EXTENSION SET, 12" MICROBORE FPA MEDICAL SPECIALTIES DISTRIBUTORS INC MS438 B2L830

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other