BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 1300320 · Received January 28, 2009

    Report

    Report Number
    MW5009776
    Event Type
    Malfunction
    Date Received
    January 28, 2009
    Report Date
    January 16, 2009
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT SAFETY CONCERN W/ THREE TUBINGS. BLOOD CAT# 100110903. CONCERN: POTENTIAL FOR AIR IN PRESSURE CHAMBER. IV GRAVITY TUBING CAT# C42006E. CONCERN: TUBING TOO SHORT AND EASILY COMPRESSED; KINKS. STOP COCKS LOOSELY CONNECTED CANNOT LUER-LOCK CONNECTIONS; CANNOT TIGHTEN. FINCH EXTENSION TUBING CAT# C20025. CONCERN: TUBING TOO SOFT; KINKS. CARDINAL HEALTH NOTIFIED OF ABOVE CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDINAL HEALTH TUBING FPA
    2 IV GRAVITY TUBING TUBING FPA
    3 FINCH EXTENSION TUBING FPA

    Patients

    Seq Age Sex Outcome Treatment
    1