BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXZERO NEEDLELESS CONNECTOR

    MDR report key: 9112498 · Received September 24, 2019

    Report

    Report Number
    9616066-2019-02721
    Event Type
    Malfunction
    Date Received
    September 24, 2019
    Date of Event
    September 2, 2019
    Report Date
    September 3, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403230196
    PMA / PMN Number
    K132413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER COMPLAINT OF LEAKING OBSERVED BETWEEN THE MAXZERO CONNECTION AND ATTACHED SYRINGE COULD NOT BE CONFIRMED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A PHOTO OF A 3ML SYRINGE WITH THE FLANGE CODE IDENTIFIED AS M-143 WAS PROVIDED BY THE CUSTOMER. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS LEAKING OBSERVED BETWEEN THE MAXZERO CONNECTOR AND THE ATTACHED SYRINGE. THERE WAS NO SIGNIFICANT DELAY IN PATIENT CARE AND NO PATIENT HARM REPORTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 3 ML SYRINGE, BD REF 309657, LOT NUMBER: 8222975. ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS LEAKING OBSERVED BETWEEN THE MAXZERO CONNECTOR AND THE ATTACHED SYRINGE. THERE WAS NO SIGNIFICANT DELAY IN PATIENT CARE AND NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907250 MAXZERO NEEDLELESS CONNECTOR SET,ADMINISTRATION,INTRAVASCULAR FPA CAREFUSION MZ1000-07 10885403230196

    Patients

    Seq Age Sex Outcome Treatment
    1 10 DA