BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANIFOLD MULTIPORT Q2 10 IN 6 PORTS IV NEEDLE FREE

    MDR report key: 13618365 · Received February 28, 2022

    Report

    Report Number
    13618365
    Event Type
    Malfunction
    Date Received
    February 28, 2022
    Date of Event
    February 1, 2022
    Report Date
    February 23, 2022
    Manufacturer
    PROGRESSIVE MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UPON RETURN TO THE POST ANESTHESIA CARE UNIT (PACU) FROM THE OPERATING ROOM (OR), THE PATIENT BEGAN HAVING DECREASED OXYGEN SATURATION (O2 SATS), INCREASED HEART RATE AND RESPIRATIONS. UPON FURTHER ASSESSMENT IT WAS NOTED THAT THE RIGHT DOUBLE LUMEN CENTRAL LINE HAD VISIBLE AIR BUBBLE- BUBBLE ASPIRATED, LINE HAD GOOD BLOOD RETURN. WHEN LOOKING CLOSER AT THE CENTRAL LINE SET UP, THE PURPLE 6 PORT "MULTI-PORT" FLUID ADAPTER WAS NOTED TO HAVE A BROKEN BLUE PORT, OPEN TO AIR. UNABLE TO LOCATE THE BLUE PART OF THE ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006423 MANIFOLD MULTIPORT Q2 10 IN 6 PORTS IV NEEDLE FREE SET, ADMINISTRATION, INTRAVASCULAR FPA PROGRESSIVE MEDICAL, INC. 9520

    Patients

    Seq Age Sex Outcome Treatment
    1 19345 DA Female