BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXPLUS NEEDLELESS CONNECTOR

    MDR report key: 3161837 · Received June 5, 2013

    Report

    Report Number
    9616066-2013-00403
    Event Type
    Death
    Date Received
    June 5, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 10, 2013
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K072542
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A F/U REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    A MAXPLUS CONNECTOR LEAKED WHILE ON A PT. THE CUSTOMER IS ASSUMING THERE IS AN INTERNAL CRACK CAUSING THE LEAK AS NONE IS SEEN EXTERNALLY. MAXPLUS WAS SAVED AND WILL BE SENT BACK FOR INVESTIGATION. THERE WAS NO PT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED FOR THIS EVENT. THE PT DID PASS AWAY A FEW DAYS LATER FROM UNRELATED ISSUES. THIS PRODUCT WAS NOT ON THE PT AT THAT TIME. CUSTOMER STATED THAT NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247991 MAXPLUS NEEDLELESS CONNECTOR FPA CAREFUSION CORP MP1000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death