BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH

    MDR report key: 12851392 · Received November 22, 2021

    Report

    Report Number
    12851392
    Event Type
    Malfunction
    Date Received
    November 22, 2021
    Date of Event
    September 23, 2021
    Report Date
    November 11, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FOZ
    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

    AFTER PLACING AN IV IN A PATIENT, THE NURSE IMMEDIATELY CALLED ADDITIONAL HEALTH CARE PROVIDERS, AND SAID THE IV WOULDN'T FLUSH. BLOOD WAS NOTED IN THE CATHETER AND HUB BUT IT HAD BEEN LESS THAN 5 MINUTES SINCE THE IV WAS PLACED SO OCCLUSION WAS UNLIKELY. IV WAS REDRESSED AND FOUND TO BE NOT KINKED AND WHEN A NEW EXTENSION AND FLUSH WAS APPLIED FLUSHED EASILY. AFTER INSPECTING THE REMOVED EXTENSION SYSTEM IT WAS FOUND THAT THE IV WOULDN'T FLUSH EVEN WITHOUT THE EXTENSION TUBING CONNECTED. THE DYSFUNCTIONAL FLUSH WAS DISCARDED AND NOTHING WAS DONE. DAYS LATER, AFTER PLACING AN IV THAT WAS BLEEDING BACK COPIOUSLY AND WAS IN CORRECT PLACEMENT, IT WOULDN'T FLUSH AFTER APPLYING THE EXTENSION TUBING WITH FLUSH ATTACHED. RECALLING THE EVENTS OF MY PREVIOUS EXPERIENCE, THE FLUSH WAS REPLACED WITH A NEW ONE WHICH FLUSHED EASILY. AFTER INSPECTION OF THE TWO FLUSHES AND CONTINUED INABILITY TO FLUSH THE DEFECTED FLUSH DESPITE NOTHING BEING CONNECTED TO IT, THEY WERE FOUND TO BE OF THE SAME LOT NUMBER (LOT #1160571) AND EXPIRATION DATE (2024-05-31). THE TWO FLUSHES (ONE FUNCTIONAL AND ONE NOT) WERE SAVED AND GIVEN TO THE UNIT EDUCATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749170 BD POSIFLUSH CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BECTON, DICKINSON AND COMPANY 306547 1160571

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown