BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXGUARD BLOOD COLLECTION TUBE HOLDER

    MDR report key: 3222017 · Received July 3, 2013

    Report

    Report Number
    9616066-2013-00496
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 13, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO DRAW BLOOD, THE NEEDLE OF THE BLOOD COLLECTION DEVICE BROKE OFF AND WAS LODGED INTO THE VACUTAINER TUBE (LEAVING AN EXPOSED NEEDLE). THERE WAS NO REPORT OF PT HARM. MEDICAL INTERVENTION WAS NOT REQUIRED. THE CUSTOMER STATED THAT NO FURTHER PT/EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304917 MAXGUARD BLOOD COLLECTION TUBE HOLDER FPA CAREFUSION CORPORATION MBC6000 301120316

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK