BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTIV SAFETY CATHETER

    MDR report key: 10572985 · Received September 23, 2020

    Report

    Report Number
    10572985
    Event Type
    Malfunction
    Date Received
    September 23, 2020
    Date of Event
    September 16, 2020
    Report Date
    September 21, 2020
    Manufacturer
    SMITHS MEDICIAL ASD, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    UPON FLUSHING A PATIENT'S IV AND CHECKING FOR BLOOD RETURN, THE RN NOTICED THAT NO BLOOD ENTERED THE SYRINGE AND THAT THE PLUNGER OF THE SYRINGE REMAINED UP. THIS SUGGESTED THAT THERE WAS NO LONGER A VACUUM IN THE IV EXTENDER AND THAT AIR MAY HAVE ENTERED IT. UPON REMOVAL OF THE IV CATHETER IT WAS FOUND THAT THERE WAS A SMALL HOLE THAT HAD FORMED JUST BELOW THE FLEXIBLE CATHETER IS ATTACHED TO THE GREEN HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038291 PROTECTIV SAFETY CATHETER NEEDLE, HYPODERMIC, SINGLE LUMEN FOZ SMITHS MEDICIAL ASD, INC. 3065

    Patients

    Seq Age Sex Outcome Treatment
    1