BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO PROTECTIV PLUS

    MDR report key: 1983756 · Received January 24, 2011

    Report

    Report Number
    1983756
    Event Type
    Malfunction
    Date Received
    January 24, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 24, 2011
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NEEDLE WOULD NOT RETRACT AND LOCK INTO THE SAFETY CHAMBER COMPLETELY. ABOUT 0.5 CM OF THE NEEDLE WAS LEFT EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JELCO PROTECTIV PLUS CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 D FOZ SMITHS MEDICAL ASD, INC. 3060 ST1900492

    Patients

    Seq Age Sex Outcome Treatment
    1 *