BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS CLEAR NEEDLELESS CONNECTOR

    MDR report key: 2891064 · Received November 14, 2012

    Report

    Report Number
    9616066-2012-00797
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 23, 2012
    Manufacturer
    CAREFUSION CORP.
    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 PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED "BLOOD SQUIRTED AFTER BLOOD DRAW, CAP REPLACED." PATIENT CARE UNIT WAS PACU. THERE WAS NO REPORT OF PATIENT HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO FURTHER PATIENT OR EVENT DETAILS WERE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK THERAPY DATE:| SYRINGE, MANUFACTURER MODE/LOT UNK