BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXGUARD BLOOD COLLECTION DEVICE

    MDR report key: 3983181 · Received June 27, 2014

    Report

    Report Number
    9616066-2014-00665
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 18, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FMH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 06/27/2014. (B)(4). ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE AFFECTED PRODUCT BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DURING A BLOOD DRAW THE RUBBER SHEATH GOT STUCK IN AN ADULT BLOOD CULTURE BOTTLE AND BLOOD LEAKED INTO THE BLOOD COLLECTION DEVICE. NO PT HARM OR MED INTERVENTION OCCURRED. NO FURTHER PT/EVENT INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377247 MAXGUARD BLOOD COLLECTION DEVICE COLLECTION DEVICE, 81K-ST FMH CAREFUSION CORP MBC6010 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK BLOOD CULTURE BOTTLE, MFR/MODEL/LOT UNK