BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXZERO NEEDLENESS CONNECTOR

    MDR report key: 9312449 · Received November 12, 2019

    Report

    Report Number
    9616066-2019-03244
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Report Date
    October 21, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K132413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT GRID REVISED FROM CAD NFV TO MZ1000-07. ADDITIONAL INFORMATION ADDED TO: D1,D2,D4,G5. SECTION B.3 REQUESTED BUT NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MAXZERO LEAKED AT CONNECTION TO THE 3ML SYRINGE DURING MEDICATION ADMINISTRATION. ALTHOUGH REQUESTED, NO FURTHER EVENT DETAILS WILL BE PROVIDED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    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. PATIENT AGE AND DOB REQUESTED BUT NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MAXZERO LEAKED AT CONNECTION TO THE 3ML SYRINGE DURING MEDICATION ADMINISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103138 MAXZERO NEEDLENESS CONNECTOR SET, EXTENSION, INTRAVASCULAR FPA CAREFUSION MZ1000-07

    Patients

    Seq Age Sex Outcome Treatment
    1 BD 3ML SYRINGE,THERAPY DATE UNKNOWN