BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

    MDR report key: 7465345 · Received April 26, 2018

    Report

    Report Number
    1917413-2018-01125
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Date of Event
    April 11, 2017
    Report Date
    April 20, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903627610
    PMA / PMN Number
    K911731
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    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 #: 6167992, MEDICAL DEVICE EXPIRATION DATE: 06/30/2017, DEVICE MANUFACTURE DATE: 06/15/2016. MEDICAL DEVICE LOT #: 6272863, MEDICAL DEVICE EXPIRATION DATE: 10/31/2017, DEVICE MANUFACTURE DATE: 09/28/2016. MEDICAL DEVICE LOT #: 6306949, MEDICAL DEVICE EXPIRATION DATE: 11/30/2017, DEVICE MANUFACTURE DATE: 11/01/2016. MEDICAL DEVICE LOT #: 6306947, MEDICAL DEVICE EXPIRATION DATE: 11/30/207, DEVICE MANUFACTURE DATE: 11/01/2016. MEDICAL DEVICE LOT #: 6167501, MEDICAL DEVICE EXPIRATION DATE: 06/30/2017, DEVICE MANUFACTURE DATE: 06/15/2016. MEDICAL DEVICE LOT #: 6061899, MEDICAL DEVICE EXPIRATION DATE: 03/31/2017, DEVICE MANUFACTURE DATE: 03/01/2016. 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 (B)(6) WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE FOR 85302 WAS NOT OBSERVED AS ALL SAMPLES MET SPECIFICATIONS. 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® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE HAD "POOR SEPARATION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307271 BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 6272862 50382903627610

    Patients

    Seq Age Sex Outcome Treatment
    1 Other