BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS EXTENSION SET

    MDR report key: 2082581 · Received April 27, 2011

    Report

    Report Number
    9616066-2011-00162
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 14, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K083472
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 04/27/2011. (B)(6). ALTHOUGH REQUESTED, THE DEVICE RELATED TO THIS EVENT WAS NOT RETURNED. UNABLE TO DETERMINE THE ROOT CAUSE OF THE CUSTOMER'S REPORTED EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AS THEY DREW BLOOD FROM EXTENSION SET AND FLUSHED THE LINE, THE BLUE CAP POPPED OFF AND BLOOD LEAKED FROM EXTENSION SET. NO PT OR CLINICIAN HARM REPORTED. NO ADD'L EVENT INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXPLUS EXTENSION SET FPA CAREFUSION CORP. MP5312-C 11025296

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK