BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 7477536 · Received May 1, 2018

    Report

    Report Number
    1024879-2018-02358
    Event Type
    Malfunction
    Date Received
    May 1, 2018
    Date of Event
    September 20, 2017
    Report Date
    May 1, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7153850, EXPIRATION DATE: 05/31/2018, MANUFACTURE DATE: 06/02/2017. MEDICAL DEVICE LOT #: 7222663, EXPIRATION DATE: 07/31/2018, MANUFACTURE DATE: 08/10/2017. MEDICAL DEVICE LOT #: 7061923, EXPIRATION DATE: 02/28/2018, MANUFACTURE DATE: 03/02/2017. MEDICAL DEVICE LOT #: 7129912, EXPIRATION DATE: 04/30/2018, MANUFACTURE DATE: 05/09/2017. MEDICAL DEVICE LOT #: 7172561, EXPIRATION DATE: 06/30/2018, MANUFACTURE DATE: 06/21/2017." 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 LOTS 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 GEL MIGRATION CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318274 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 7164937 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other