BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ACD SOLUTION A BLOOD COLLECTION TUBES

    MDR report key: 7469724 · Received April 27, 2018

    Report

    Report Number
    1917413-2018-01115
    Event Type
    Malfunction
    Date Received
    April 27, 2018
    Date of Event
    April 21, 2017
    Report Date
    May 31, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903646062
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # CHANGED TO PREAMENDMENT.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 5041739, MEDICAL DEVICE EXPIRATION DATE: 02/28/2017, DEVICE MANUFACTURE DATE: 02/10/2015, MEDICAL DEVICE LOT #: 5175657, MEDICAL DEVICE EXPIRATION DATE: 07/31/2017, DEVICE MANUFACTURE DATE: 06/24/2015, MEDICAL DEVICE LOT #: 5272527, MEDICAL DEVICE EXPIRATION DATE: 10/31/2017, DEVICE MANUFACTURE DATE: 09/29/2015, MEDICAL DEVICE LOT #: 5336527, MEDICAL DEVICE EXPIRATION DATE: 12/31/2017, DEVICE MANUFACTURE DATE: 12/02/2015, MEDICAL DEVICE LOT #: 6063543, MEDICAL DEVICE EXPIRATION DATE: 03/31/2018, DEVICE MANUFACTURE DATE: 03/03/2016, MEDICAL DEVICE LOT #: 6090798, MEDICAL DEVICE EXPIRATION DATE: 04/30/2018, DEVICE MANUFACTURE DATE: 03/30/2016, MEDICAL DEVICE LOT #: 6123855, MEDICAL DEVICE EXPIRATION DATE: 05/31/2018, DEVICE MANUFACTURE DATE: 05/02/2016, MEDICAL DEVICE LOT #: 6161936, MEDICAL DEVICE EXPIRATION DATE: 06/30/2018, DEVICE MANUFACTURE DATE: 06/09/2016, MEDICAL DEVICE LOT #: 5356756, MEDICAL DEVICE EXPIRATION DATE: 01/31/2018, DEVICE MANUFACTURE DATE: 12/22/2015. PMA/510(K) #: THERE IS NO 510(K) FOR THIS DEVICE, IT ONLY SAYS "PRE-AMENDMENT" WHERE THE 510(K) SHOULD BE. BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR (B)(6) 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 BD VACUTAINER® ACD SOLUTION A BLOOD COLLECTION TUBES HAD MISSING IVD MARKS ON THE LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313538 BD VACUTAINER® ACD SOLUTION A BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 6187968 50382903646062

    Patients

    Seq Age Sex Outcome Treatment
    1 Other