BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BLOOD COLLECTION TUBES BUFFERED SODIUM CITRATE 0.3ML - 0.109M

    MDR report key: 7601859 · Received June 14, 2018

    Report

    Report Number
    9617032-2018-01659
    Event Type
    Malfunction
    Date Received
    June 14, 2018
    Date of Event
    May 20, 2016
    Report Date
    May 24, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903643054
    PMA / PMN Number
    K013971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL LOT NUMBER IS AS FOLLOWS: DEVICE MANUFACTURE DATE: 09/08/2015. MEDICAL DEVICE EXPIRATION DATE: 06/30/2016. MEDICAL DEVICE LOT #: 5251324. BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE WITH THE INCIDENT LOT WAS NOT OBSERVED. 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 THAT THE BD VACUTAINER® BLOOD COLLECTION TUBES BUFFERED SODIUM CITRATE 0.3ML - 0.109M HAD ISSUES WITH BLOOD FILLING IN THE TUBE. NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442713 BD VACUTAINER® BLOOD COLLECTION TUBES BUFFERED SODIUM CITRATE 0.3ML - 0.109M BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 6067775 50382903643054

    Patients

    Seq Age Sex Outcome Treatment
    1 Other