BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 12610486 · Received October 11, 2021

    Report

    Report Number
    1024879-2021-00701
    Event Type
    Malfunction
    Date Received
    October 11, 2021
    Date of Event
    September 13, 2021
    Report Date
    July 12, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 01-NOV-2021. INVESTIGATION SUMMARY: MATERIAL #: 367986. LOT/BATCH #: 0329777, 1176688, 1041711, 1176690, 1144785. BD RECEIVED 8 SAMPLES AND 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WAS OBSERVED. ADDITIONALLY, CUSTOMER SAMPLES WERE EVALUATED ALONG WITH RETENTION SAMPLES OF THE INCIDENT LOT SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, THE INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WAS NOT OBSERVED. 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 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. TESTING WAS PERFORMED ON RETAINED TUBES DUE TO INADEQUATE NUMBER OF CUSTOMER SAMPLES FOR CLINICAL EVALUATION. 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 THE INDICATED FAILURE MODE POOR BARRIER SEPARATION BASED ON PHOTOS ONLY. 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

    AN ADDITIONAL LOT NUMBER WAS PROVIDED. THE INFORMATION FOR THIS LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 1144785. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-05-31. H.4. DEVICE MANUFACTURE DATE: 2021-05-21.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0329777 MEDICAL DEVICE EXPIRATION DATE: 2021-11-30 DEVICE MANUFACTURE DATE: 2020-11-24. MEDICAL DEVICE LOT #: 1176688 MEDICAL DEVICE EXPIRATION DATE: 2022-06-30 DEVICE MANUFACTURE DATE: 2021-06-25. MEDICAL DEVICE LOT #: 1041711 MEDICAL DEVICE EXPIRATION DATE: 2022-02-28 DEVICE MANUFACTURE DATE: 2021-02-10. MEDICAL DEVICE LOT #: 1176690 MEDICAL DEVICE EXPIRATION DATE: 2021-11-30 DEVICE MANUFACTURE DATE: 2020-11-24. 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 WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE THERE WAS POOR BARRIER SEPARATION OF SAMPLE. THIS EVENT OCCURRED 4 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE ARE WITNESSING GEL SEPARATOR NOT SEPARATING PROPERLY."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE THERE WAS POOR BARRIER SEPARATION OF SAMPLE. THIS EVENT OCCURRED 4 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE ARE WITNESSING GEL SEPARATOR NOT SEPARATING PROPERLY."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE THERE WAS POOR BARRIER SEPARATION OF SAMPLE. THIS EVENT OCCURRED 4 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE ARE WITNESSING GEL SEPARATOR NOT SEPARATING PROPERLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504189 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 NA Unknown