BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROCLAVE® STABILIZED EXTENSION SET

    MDR report key: 17236866 · Received June 30, 2023

    Report

    Report Number
    17236866
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Date of Event
    June 11, 2023
    Report Date
    June 16, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS HAS BEEN INTERMITTENTLY HAPPENING OVER THE PAST WEEK WHERE THE VELANOVASCULAR EXT STABILIZED EXTENSION SET HAS A DEFECT CAUSING BLOOD TO POUR OUT WHEN IT'S HOOKED UP TO IV CATHETER UPON INITIAL INSERTION. SOME OTHER SUPPLIES WERE KEPT AND PROVIDED TO MANAGEMENT , SO I DO NOT HAVE THOSE LOT NUMBERS, BUT TODAY THE PACKAGING LOT #9453943. I HAVE BEEN GETTING 2-3 DEVICES DOING THIS PER DAY WHEN I'VE BEEN CHARGING, WITH IV STARTS. POTENTIAL FOR SAFETY ISSUE AS THIS EXPOSES STAFF TO BLOOD UNEXPECTEDLY AND MAY CAUSE MALFUNCTION OF IV SITE REQUIRING RE-START. THIS PARTICULAR PATIENT WAS A VERY DIFFICULT IV START REQUIRING IV US PLACEMENT. MANUFACTURER RESPONSE FOR SET EXTENSION EXT STABILIZED GEN 2 201-0, (BRAND NOT PROVIDED) (PER SITE REPORTER) EMAILED VENDOR - NO RESPONSE YET.

    Description of Event or Problem · 0

    THIS HAS BEEN INTERMITTENTLY HAPPENING OVER THE PAST WEEK WHERE THE VELANOVASCULAR EXT STABILIZED EXTENSION SET HAS A DEFECT CAUSING BLOOD TO POUR OUT WHEN IT'S HOOKED UP TO IV CATHETER UPON INITIAL INSERTION. SOME OTHER SUPPLIES WERE KEPT AND PROVIDED TO MANAGEMENT , SO I DO NOT HAVE THOSE LOT NUMBERS, BUT TODAY THE PACKAGING LOT #9453943. I HAVE BEEN GETTING 2-3 DEVICES DOING THIS PER DAY WHEN I'VE BEEN CHARGING, WITH IV STARTS. POTENTIAL FOR SAFETY ISSUE AS THIS EXPOSES STAFF TO BLOOD UNEXPECTEDLY AND MAY CAUSE MALFUNCTION OF IV SITE REQUIRING RE-START. THIS PARTICULAR PATIENT WAS A VERY DIFFICULT IV START REQUIRING IV US PLACEMENT. MANUFACTURER RESPONSE FOR SET EXTENSION EXT STABILIZED GEN 2 201-0, (BRAND NOT PROVIDED) (PER SITE REPORTER). EMAILED VENDOR - NO RESPONSE YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988915 BD MICROCLAVE® STABILIZED EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON 9453943

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown