BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECT IV PLUS W SAFETY IV CATHETER

    MDR report key: 1905847 · Received November 16, 2010

    Report

    Report Number
    MW5018268
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    November 14, 2010
    Report Date
    November 16, 2010
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PIV ATTEMPT ON PT - CATHETER SHEARED DURING THE PROCESS. A 22G 1 INCH PROTECT IV PLUS-W SAFETY IV CATHETER. JELCO REF (B)(4), LOT ST1861530.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECT IV PLUS W SAFETY IV CATHETER JELCO 22 G PERIPHERAL IV FOZ SMITHS MEDICAL 3080 ST1861530

    Patients

    Seq Age Sex Outcome Treatment
    1 Other