BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXZERO NEEDLELESS CONNECTOR

    MDR report key: 9553083 · Received January 6, 2020

    Report

    Report Number
    9616066-2020-00022
    Event Type
    Malfunction
    Date Received
    January 6, 2020
    Date of Event
    December 15, 2019
    Report Date
    December 15, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K132413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION ADDED TO: D10. A VISUAL INSPECTION CONFIRMED THREE LONGITUDINAL CRACKS TO THE FEMALE LUER OF THE MAXZERO VALVE; LEAKAGE WAS OBSERVED FROM THE CRACKS DURING A FLUSH THROUGH. A REVIEW OF THE PRODUCTION RECORDS DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. ALTHOUGH POTENTIAL ROOT CAUSES WERE IDENTIFIED DURING A REVIEW OF THE MANUFACTURING PROCESS, THERE IS NO EVIDENCE OF THIS CONTRIBUTING TO THE FAILURE MODE.

    Description of Event or Problem · 0

    THE REPORTED FEEDBACK SUGGESTS THAT THE BLUE SOFT PLUG IN THE MIDDLE IS DEFORMED AND CRACKED.

    Additional Manufacturer Narrative · 1

    MZ1000 CHINA/NO 510K THIS IS AN INTERNATIONAL CODE- THE MODEL#/CATALOG# IDENTIFIED IN SECTION IS A CAREFUSION PRODUCT WHICH IS SAME OR SIMILAR TO A DEVICE THAT IS APPROVED FOR SALE DOMESTICALLY. THE DOMESTIC SIMILAR LIST NUMBER IS MZ1000-07. THE 510K NUMBER PROVIDED IN SECTION IS FOR THE DOMESTIC SIMILAR PRODUCT - K132413. ALTHOUGH REQUESTED, PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE PRODUCT BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE REPORTED FEEDBACK SUGGESTS THAT THE BLUE SOFT PLUG IN THE MIDDLE IS DEFORMED AND CRACKED. REPORT SUGGESTS NOT IN USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16390 MAXZERO NEEDLELESS CONNECTOR SET, EXTENSION, INTRAVASCULAR FPA CAREFUSION MZ1000 CHINA 19025573

    Patients

    Seq Age Sex Outcome Treatment
    1