BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 16096025 · Received January 4, 2023

    Report

    Report Number
    1024879-2022-00752
    Event Type
    Malfunction
    Date Received
    January 4, 2023
    Date of Event
    December 7, 2022
    Report Date
    April 20, 2023
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 THE INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION AND GEL SMEARING WAS OBSERVED FOR LOT # 2217113. ADDITIONALLY, 30 RETENTION SAMPLES FROM EACH INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR VISUAL INSPECTION AND UPON COMPLETION, THE INDICATED FAILURE MODE FOR GEL SMEARING WAS NOT OBSERVED. POOR BARRIER SEPARATION CANNOT BE OBSERVED THROUGH RETAIN INSPECTION. FURTHER CLINICAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR POOR BARRIER SEPARATION AND GEL SMEARING: THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO DUPLICATE THE CUSTOMER¿S INDICATED FAILURE MODES, POOR BARRIER AND GEL SMEARING, BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. ALL VISUAL OBSERVATIONS OF BOTH RETAIN AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. ALL TUBES PERFORMED AS EXPECTED. 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. THIS COMPLAINT HAS BEEN CONFIRMED FOR POOR BARRIER SEPARATION AND GEL SMEARING ON LOT 2217113 BASED ON THE PHOTOS PROVIDED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE REPORTED DEFECTS FOR LOT #'S 2200856, 2213778, AND 2201052. ALL TESTING OF RETENTION SAMPLES WAS SATISFACTORY. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2217113, MEDICAL DEVICE EXPIRATION DATE: 07/31/2023, DEVICE MANUFACTURE DATE: 07/31/2022. MEDICAL DEVICE LOT #: 2200856, MEDICAL DEVICE EXPIRATION DATE: 07/31/2023, DEVICE MANUFACTURE DATE: 07/19/2022. MEDICAL DEVICE LOT #: 2213778, MEDICAL DEVICE EXPIRATION DATE: 07/31/2023, DEVICE MANUFACTURE DATE: 08/01/2022. MEDICAL DEVICE LOT #: 2201052, MEDICAL DEVICE EXPIRATION DATE: 07/31/2023, DEVICE MANUFACTURE DATE: 07/20/2022. 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 · 0

    IT WAS REPORTED BY THE CUSTOMER THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES FROM 4 LOTS HAD POOR BARRIER SEPARATION AND SMEARED GEL. LOTS 2159263, 2200856, AND 2201052 ALL HAD NOTED ISSUES WITH GEL SEPARATION AND 'STREAKING' OF GEL ON THE SIDES OF THE TUBES. AMOUNTS AFFECTED FOR THESE LOTS IS NOT AVAILABLE. CUSTOMER STATES INCOMPLETE GEL SEPARATION FOR LOT # 2217113, 2200856, 2213778, 2201052.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES FROM 4 LOTS HAD POOR BARRIER SEPARATION AND SMEARED GEL LOTS 2159263, 2200856, AND 2201052 ALL HAD NOTED ISSUES WITH GEL SEPARATION AND 'STREAKING' OF GEL ON THE SIDES OF THE TUBES. AMOUNTS AFFECTED FOR THESE LOTS IS NOT AVAILABLE. CUSTOMER STATES INCOMPLETE GEL SEPARATION FOR LOT # 2217113, 2200856, 2213778, 2201052. LOT # 2159263 IS CAPTURED IN A RELATED COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177364 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367986 SEE H.10. 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown