BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MADEX PROTECTIV PLUS

    MDR report key: 768080 · Received October 10, 2006

    Report

    Report Number
    MW1040632
    Event Type
    Injury
    Date Received
    October 10, 2006
    Date of Event
    September 25, 2006
    Report Date
    October 4, 2006
    Manufacturer
    SMITHS MEDICAL M.D. INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 9/25/2006, INSERTION OF 22G 1" PROTECTIV IV PLUS CATHETER INSERTED, RESISTANCE FELT, CATHETER PULLED BACK UNTIL NO RESISTANCE FELT. GOOD BLOOD RETURN NOTED. UPON FLUSHING. INJECTION NOTED. CATHETER REMOVED. NOTED ONLY HALF OF CATHETER RETURNED. SUPERVISOR NOTIFIED, PT'S PHYSICIAN NOTIFIED AND SURGEON ON-CALL NOTIFIED AT REQUEST OF PHYSICIAN. INSTRUCTIONS RECEIVED FROM SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MADEX PROTECTIV PLUS IV CATH (PROTECTIV PLUS) 22G FOZ SMITHS MEDICAL M.D. INC. 3060 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Hospitalization| R