BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    13X75MM 4.0ML BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE.LAVENDER BD HEMOGARD¿

    MDR report key: 7059112 · Received November 27, 2017

    Report

    Report Number
    1917413-2017-00229
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    January 25, 2016
    Report Date
    October 31, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903678629
    PMA / PMN Number
    K981013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A PHOTO WAS SENT THAT SHOWED THE ISSUE. A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT #5120677. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED ON THE 13X75MM 4.0ML BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE. LAVENDER BD HEMOGARD¿ HAD A MISPRINTED LABEL. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838872 13X75MM 4.0ML BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE.LAVENDER BD HEMOGARD¿ BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO. 5120677 50382903678629

    Patients

    Seq Age Sex Outcome Treatment
    1 Other