BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 15879758 · Received November 29, 2022

    Report

    Report Number
    9617032-2022-01213
    Event Type
    Malfunction
    Date Received
    November 29, 2022
    Date of Event
    November 8, 2022
    Report Date
    February 15, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    00382903679539
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2084347, MEDICAL DEVICE EXPIRATION DATE: 2023-09-30, DEVICE MANUFACTURE DATE: 2022-03-25. MEDICAL DEVICE LOT #: 2080645, MEDICAL DEVICE EXPIRATION DATE: 2023-09-30, DEVICE MANUFACTURE DATE: 2022-03-21, MEDICAL DEVICE LOT #: 2095139, MEDICAL DEVICE EXPIRATION DATE: 2023-10-31, DEVICE MANUFACTURE DATE: 2022-04-05. MEDICAL DEVICE LOT #: 2095146, MEDICAL DEVICE EXPIRATION DATE: 2023-10-31, DEVICE MANUFACTURE DATE: 2022-04-05. INITIAL REPORTER EMAIL: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 2023-01-13. H.6. INVESTIGATION SUMMARY: BD RECEIVED 4 SAMPLES (2 EACH FROM LOTS 2095146 AND 2095139) AND 3 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WAS NOT OBSERVED. CLINICAL TESTING COULD NOT BE PERFORMED ON THE RETURN SAMPLES RECEIVED DUE TO THE VOLUME OF SAMPLES NEEDED FOR TESTING; THEREFORE RETENTION SAMPLES FROM THE INDICATED LOT NUMBERS WERE TESTED. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES EXHIBITED PROPER FILL. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE, (POOR BARRIER SEPARATION) 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 IS UNABLE TO BE CONFIRMED FOR POOR BARRIER SEPARATION. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. FACTORS THAT MAY CONTRIBUTE TO POOR BARRIER SEPARATION WERE EVALUATED THROUGH A CLINICAL STUDY TO VERIFY THE DESIGN OF THE DEVICE MET IT¿S INTENDED USE. THE RESULT OF THE STUDY SHOWED THAT THE DEVICE PERFORMED AS EXPECTED AND WE WERE UNABLE TO DETERMINE ANY EXTERNAL CONTRIBUTOR TO THIS REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED POOR BARRIER SEPARATION OF THE SAMPLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: FEEDBACK ON 367953 SST II GEL SEPARATING THE CELLS AND SERUM ARE NOT CLEAR, WITH BLOOD CELLS SEEM ON THE GEL BARRIER. RED CELLS ARE SEEN FLOATING IN SERUM CAUSES COMPROMISED IN SAMPLE QUALITY.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED POOR BARRIER SEPARATION OF THE SAMPLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: FEEDBACK ON 367953 SST II GEL SEPARATING THE CELLS AND SERUM ARE NOT CLEAR, WITH BLOOD CELLS SEEM ON THE GEL BARRIER. RED CELLS ARE SEEN FLOATING IN SERUM CAUSES COMPROMISED IN SAMPLE QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946660 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10. 00382903679539

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown