BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E 5.4MG PLUS BLOOD COLLECTION TUBE

    MDR report key: 7436470 · Received April 17, 2018

    Report

    Report Number
    9617032-2018-00447
    Event Type
    Malfunction
    Date Received
    April 17, 2018
    Date of Event
    October 26, 2016
    Report Date
    April 13, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO POTENTIAL LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS:  MEDICAL DEVICE LOT #: 6153605. MEDICAL DEVICE EXPIRATION DATE: 2017-09-30.  DEVICE MANUFACTURE DATE: 2016-06-01. MEDICAL DEVICE LOT #: 6243870. MEDICAL DEVICE EXPIRATION DATE: 2017-12-31. DEVICE MANUFACTURE DATE: 2016-08-30. (B)(6). INVESTIGATION RESULTS: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR STOPPER COCKED WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED A BD VACUTAINER® K2E 5.4MG PLUS BLOOD COLLECTION TUBE WAS FOUND WITH THE STOPPER COCKED AND WOULD NOT CORRECTLY POSITION IN THE ANALYZER WHICH COULD RESULT IN LEAKAGE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281342 BD VACUTAINER® K2E 5.4MG PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other