BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXZERO CONNECTOR

    MDR report key: 7762434 · Received August 7, 2018

    Report

    Report Number
    MW5078933
    Event Type
    Malfunction
    Date Received
    August 7, 2018
    Date of Event
    May 1, 2018
    Report Date
    August 3, 2018
    Manufacturer
    BECTON DICKINSON / CAREFUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AT (B)(6) HOSPITAL WE HAVE BEEN FINDING SLOW LEAKS DEVELOPING AT THE CONNECTION POINT OF BD CAREFUSION TUBING INFUSION TUBING TO BD CAREFUSION MAXZERO CONNECTORS. IT IS HAPPENING WITH DIFFERENT TUBING AND DIFFERENT PRODUCTS BEING INFUSED BUT ALWAYS THROUGH THE MAXZERO CONNECTOR. THIS CAUSES US TO SWAP OUT THE CONNECTOR, BI- TRI-, AND QUAD-FUSES MORE FREQUENTLY INTRODUCING OPPORTUNITY FOR INFECTION/CONTAMINATION. WE HAVE SEEN THIS ON MULTIPLE PTS, AND WITH VARIOUS TUBING SETUPS. IT OCCURS MOST FREQUENTLY IN VERY SMALL, SLOW INFUSIONS AND IS IMPACTING OUR ICU PTS. THERAPY START DATE: (B)(6) 2018; THERAPY END DATE: (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601176 MAXZERO CONNECTOR CATHETER, INTRAVASCULAR, THERAPEUTIC FPA BECTON DICKINSON / CAREFUSION MZ1000-07
    601177 BI-FUSES WITH MAXZERO CONNECTORS CATHETER, INTRAVASCULAR, THERAPEUTIC LJS BECTON DICKINSON / CAREFUSION MZ5307
    601178 TRI-FUSES WITH MAXZERO CONNECTORS CATHETER, INTRAVASCULAR, THERAPEUTIC LJS BECTON DICKINSON / CAREFUSION
    601179 QUAD-FUSES WITH MAXZERO CONNECTORS CATHETER, INTRAVASCULAR, THERAPEUTIC LJS BECTON DICKINSON / CAREFUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other