BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JELCO PROTECT IV PLUS W

    MDR report key: 1852865 · Received September 29, 2010

    Report

    Report Number
    MW5017616
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    September 11, 2010
    Report Date
    September 19, 2010
    Manufacturer
    SMITHS-MEDICAL
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A #24 5/8 INCH JELCO SMITHS-MEDICAL WAS INSERTED IN ANTECUBITAL OF (B)(6) INFANT. WHEN CATHETER REMOVED, ONLY ABOUT 1/16 INCH OF PLASTIC CATHETER WAS STILL ATTACHED TO THE HUB. IT WAS PRESUMED THAT THE REMAINDER OF THE CATHETER HAD SHEARED OFF AND WAS INSIDE THE PT'S VEIN. PT WAS TRANSFERRED TO A HIGHER LEVEL OF CARE FOR VASCULAR ASSESSMENT AND REMOVAL. THE RECEIVING FACILITY COULD NOT LOCATE THE CATHETER ON ARM, SHOULDER, CHEST AND NECK X-RAYS. THE INFANT WAS DISCHARGED HOME. DATES OF USE: (B)(6) 2010 -- (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: IV FLUIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JELCO PROTECT IV PLUS W IV CATHETER FOZ SMITHS-MEDICAL 3083 ST1815626

    Patients

    Seq Age Sex Outcome Treatment
    1 19 MO Other| R