BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXZERO NEEDLELESS CONNECTOR

    MDR report key: 7861762 · Received September 10, 2018

    Report

    Report Number
    9616066-2018-01623
    Event Type
    Malfunction
    Date Received
    September 10, 2018
    Date of Event
    July 20, 2018
    Report Date
    August 20, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403230196
    PMA / PMN Number
    K132413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S REPORT OF LEAKING FROM WHERE THE TUBING WAS ATTACHED TO THE MAXZERO CONNECTOR WAS CONFIRMED. VISUAL INSPECTION SHOWED A CRACK RUNNING ALONG ONE SIDE OF THE TOP OF THE VALVE AND CONTINUING ALONG THE THREADS OF THE VALVE. FUNCTIONAL TESTING AND PRESSURE TESTING SHOWED THAT FLUID WAS LEAKING AT THE ENGAGEMENT OF THE SET'S EXIT LUER END AND THE VALVE. THE ROOT CAUSE OF THE CUSTOMER'S REPORT WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT WHILE THE CLINICIAN WAS SCREWING THE LIPID SYRINGE ONTO THE Y-SITE OF THE NON-BD TUBING THE CLINICIAN HEARD A CLICK/CRACKING SOUND. THEN THE CLINICIAN NOTED THE LINE WAS LEAKING ONTO THE PATIENT'S BED FROM WHERE THE TUBING WAS ATTACHED TO THE MAXZERO CONNECTOR. THE PATIENT WAS ALSO RECEIVING EPINEPHRINE AND PGE THROUGH THIS LINE THEREFORE THE CLINICIAN CHANGED THE MAXZERO CONNECTOR TO RESOLVE THE LEAK. THERE WAS NO PATIENT HARM.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: SMITHS MEDICAL MX448HL60 TUBING SET AND AN UNKNOWN N21191 SET WERE USED. 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

    THE CUSTOMER REPORTED THAT WHILE THE CLINICIAN WAS SCREWING THE LIPID SYRINGE ONTO THE Y-SITE OF THE NONBD TUBING THE CLINICIAN HEARD A CLICK/CRACKING SOUND. THEN THE CLINICIAN NOTED THE LINE WAS LEAKING ONTO THE PATIENT'S BED FROM WHERE THE TUBING WAS ATTACHED TO THE MAXZERO CONNECTOR. THE PATIENT WAS ALSO RECEIVING EPINEPHRINE AND PGE THROUGH THIS LINE THEREFORE THE CLINICIAN CHANGED THE MAXZERO CONNECTOR TO RESOLVE THE LEAK. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702874 MAXZERO NEEDLELESS CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION MZ1000-07 10885403230196

    Patients

    Seq Age Sex Outcome Treatment
    1