BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXZERO NEEDLELESS CONNECTOR

    MDR report key: 4210340 · Received August 8, 2014

    Report

    Report Number
    9616066-2014-00787
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Report Date
    July 24, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K132413
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED LEAK BECAUSE THE PRODUCT HAS BEEN DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHILE DISCONNECTING THE PATIENT FROM HIS BLOOD TRANSFUSION, BLOOD SQUIRTED OUT OF THE END OF THE MAXZERO ONTO THE USER AND THE PATIENT. THERE WAS NO REPORT OF PATIENT/STAFF HARM OR MEDICAL INTERVENTION. NO FURTHER PATIENT/EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470652 MAXZERO NEEDLELESS CONNECTOR IV SET CONNECTOR FPA CAREFUSION CORPORATION MZ1000-07 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK HICKMAN CATHETER, MODEL/LOT: UNK