BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE

    MDR report key: 6999310 · Received November 3, 2017

    Report

    Report Number
    1917413-2017-00273
    Event Type
    Malfunction
    Date Received
    November 3, 2017
    Date of Event
    October 11, 2017
    Report Date
    December 11, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903678612
    PMA / PMN Number
    K981013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER WAS REPORTED INCORRECTLY AS 10/11/2107. THE CORRECT DATE IS 10/11/2017.

    Additional Manufacturer Narrative · 1

    BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR CRACKED TUBES WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR CRACKED TUBES WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE OF THE BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE THE CUSTOMER STATES MANY TUBES ARE CRACKED IN SHELF PACK. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779909 BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE BLOOD COLLECTION SET JKA BECTON, DICKINSON & CO. 7157793 50382903678612

    Patients

    Seq Age Sex Outcome Treatment
    1 Other