BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXPLUS CLEAR NEEDLELESS CONNECTOR

    MDR report key: 3736261 · Received April 2, 2014

    Report

    Report Number
    9616066-2014-00295
    Event Type
    Injury
    Date Received
    April 2, 2014
    Report Date
    March 12, 2014
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K072542
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT OF THE MALE LUER ON THE SMITH MEDICAL SAF-T HOLDER BROKE OFF INSIDE OF THE MAXPLUS VALVE COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE MALE LUER ON THE SMITH MEDICAL SAF-T HOLDER BROKE OFF INSIDE OF THE MAXPLUS VALVE. WHEN THE USER DISCONNECTED THE SMITH MEDICAL SAF-T HOLDER FROM THE MAXPLUS VALVE, SHE WAS SPRAYED IN THE FACE WITH BLOOD. THE USER WAS EVALUATED BY EMPLOYEE HEALTH AND BLOOD WAS DRAWN FOR TESTING. THE USER IS SCHEDULED TO FOLLOW UP WITH EMPLOYEE HEALTH IN 6 MONTHS. THERE WAS NO REPORT OF PATIENT HARM OR MEDICAL INTERVENTION; HOWEVER, USER HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. ALTHOUGH REQUESTED, NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199792 MAXPLUS CLEAR NEEDLELESS CONNECTOR FPA CAREFUSION CORP. MP1000-C UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other THERAPY DATE| SMITH MEDICAL PRODUCT # 960000S, LOT #UNK| SAF-T HOLDER