BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 7484952 · Received May 3, 2018

    Report

    Report Number
    1024879-2018-00740
    Event Type
    Malfunction
    Date Received
    May 3, 2018
    Date of Event
    August 16, 2017
    Report Date
    April 26, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL LOT NUMBERS IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7153851; MEDICAL DEVICE EXPIRATION DATE: 05/31/2018; DEVICE MANUFACTURE DATE: 06/02/2017. MEDICAL DEVICE LOT #: 7061923; MEDICAL DEVICE EXPIRATION DATE: 02/28/2018; DEVICE MANUFACTURE DATE: 03/02/2017; MEDICAL DEVICE LOT #: 7164938; MEDICAL DEVICE EXPIRATION DATE: 05/31/2018; DEVICE MANUFACTURE DATE: 06/13/2017; MEDICAL DEVICE LOT #: 7074711; MEDICAL DEVICE EXPIRATION DATE: 03/31/2018; DEVICE MANUFACTURE DATE: 03/15/2017; MEDICAL DEVICE LOT #: 7153850; MEDICAL DEVICE EXPIRATION DATE: 05/31/2018; DEVICE MANUFACTURE DATE: 06/02/2017; MEDICAL DEVICE LOT #: 7164937; MEDICAL DEVICE EXPIRATION DATE: 05/31/2018; DEVICE MANUFACTURE DATE: 06/13/2017; MEDICAL DEVICE LOT #: 7058895; MEDICAL DEVICE EXPIRATION DATE: 02/28/2018 ; DEVICE MANUFACTURE DATE: 02/272017; " BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. BD HAS INITIATED A CAPA TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE(S) OF THIS PRODUCT ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD INCOMPLETE GEL MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325508 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 7110747 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other