BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECT IV - PLUS W SAFETY I.V. CATHETER-RADIOPAQUE

    MDR report key: 1983625 · Received February 4, 2011

    Report

    Report Number
    MW5019315
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    January 30, 2011
    Report Date
    February 4, 2011
    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

    PROTECT IV-PLUS W SAFETY I.V. CATHETER - RADIOPAQUE. 22G 11". (B)(4), LOT: ST1895907. CATHETER SPLIT AT THE TIP DURING PIV INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECT IV - PLUS W SAFETY I.V. CATHETER-RADIOPAQUE JELCO 22 G IV FOZ SMITHS MEDICAL 3080 ST1895907

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability