BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS CLEAR NEEDLELESS CONNECTOR

    MDR report key: 2873457 · Received November 15, 2012

    Report

    Report Number
    9616066-2012-00856
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    November 6, 2012
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K072542
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    UNEXPECTED PRODUCT RETURNED. NOTE ATTACHED TO PRODUCT "CAP WAS CONNECTED TO Y-SITE PORT. NURSE FINISHED FLUSH ON MAIN CAP OF PORT TUBING. SALINE AND BLOOD SQUIRTED OUT QUITE FORCEFULLY FROM OTHER CAP ON Y-SITE. SPRAYED PT, NURSE AND BEDSIDE TABLE." THERE WAS NO PT OR STAFF HARM REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER DID NOT PROVIDE ANY ADDITIONAL EVENT OR PT INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK