BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST

    MDR report key: 11415964 · Received March 4, 2021

    Report

    Report Number
    1024879-2021-00155
    Event Type
    Malfunction
    Date Received
    March 4, 2021
    Date of Event
    February 12, 2021
    Report Date
    March 8, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679831
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND IT SHOWED THE CLOTTING AGENT WHICH IS SPRAYED INTO THE TUBE. THE COATING/ADDITIVE APPEARED NORMAL, NO DEFECTS WERE OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD VACUTAINER® SST¿ THE ADDITIVE WAS DISCOLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE WERE STAINS ON THE INSIDE OF THE TUBE.

    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 #: 0323692. MEDICAL DEVICE EXPIRATION DATE: 2021-11-30. DEVICE MANUFACTURE DATE: 2020-11-18. MEDICAL DEVICE LOT #: 0338190. MEDICAL DEVICE EXPIRATION DATE: 2021-11-30. DEVICE MANUFACTURE DATE: 2020-12-03. MEDICAL DEVICE LOT #: 0338189. MEDICAL DEVICE EXPIRATION DATE: 2021-11-30. DEVICE MANUFACTURE DATE: 2020-12-03. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE WITH BD VACUTAINER® SST¿ THE ADDITIVE WAS DISCOLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE WERE STAINS ON THE INSIDE OF THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313361 BD VACUTAINER SST TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON, DICKINSON & CO., (BD) 367983 SEE H.10 50382903679831

    Patients

    Seq Age Sex Outcome Treatment
    1