BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTIV PLUS

    MDR report key: 2792015 · Received September 21, 2012

    Report

    Report Number
    2792015
    Event Type
    Malfunction
    Date Received
    September 21, 2012
    Date of Event
    June 12, 2012
    Report Date
    September 21, 2012
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    RN NOTICED A RUSTY-COLORED SMUDGE ON THE CAP OF THE NEEDLE FOR AN IV CATHETER, WHILE THE PACKAGING WAS STILL SEALED. PACKAGED PRODUCT WAS SEQUESTERED AND REMOVED FROM CARE. AFTER FURTHER INVESTIGATION, CONTAMINANT WAS FOUND TO BE SUPERFICIAL ON THE CAP OF THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTIV PLUS SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL 3080 ST2178289

    Patients

    Seq Age Sex Outcome Treatment
    1 *