BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 17083919 · Received June 7, 2023

    Report

    Report Number
    1024879-2023-00357
    Event Type
    Malfunction
    Date Received
    June 7, 2023
    Date of Event
    May 15, 2023
    Report Date
    July 26, 2023
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679886
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2181523 D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-06-30 H.4. DEVICE MANUFACTURE DATE: 2022-06-30 D.4. MEDICAL DEVICE LOT #: 2236531 D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31 H.4. DEVICE MANUFACTURE DATE: 2022-08-24 D.4. MEDICAL DEVICE LOT #: 2244695 D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31 H.4. DEVICE MANUFACTURE DATE: 2022-09-01 H.3. 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

    H.6. INVESTIGATION SUMMARY: MATERIAL#: 367988; LOT/BATCH #: 2181523, 2236531, 2244695. TWO CUSTOMER PHOTOS WERE RECEIVED FOR REVIEW AND ANALYSIS. AFTER REVIEW AND ANALYSIS OF THE CUSTOMER RECEIVED PHOTO, SHOWING MULTIPLE TUBES WITH LOW DRAW VOLUME. THEREFORE, BD IS ABLE TO CONFIRM THE CUSTOMERS REPORTED DEFECT OF UNDERFILL FROM THE CUSTOMER PHOTOS. RETAIN TESTING CANNOT BE COMPLETED DUE TO BATCH# 2181523 BEING EXPIRED. (PRODUCT WAS USED BY THE CUSTOMER PRIOR TO THE EXPIRATION DATE). BD MAKES NO CLAIMS ON EXPIRED PRODUCT. IN ADDITION, 20 RETAIN SAMPLES WERE SUBJECTED TO A DRAW TEST FOR LOW OR NO DRAW FOR LOT# 2236531. ALL TUBES WERE WITHIN SPECIFICATION. THEREFORE, BD IS NOT ABLE TO DUPLICATE THE CUSTOMERS REPORTED FAILURE MODE WITH THE RETAIN SAMPLE TEST RESULTS. IN ADDITION, 20 RETAIN SAMPLES WERE SUBJECTED TO A DRAW TEST FOR LOW OR NO DRAW FOR LOT# 2244695. ALL TUBES WERE WITHIN SPECIFICATION. THEREFORE, BD IS NOT ABLE TO DUPLICATE THE CUSTOMERS REPORTED FAILURE MODE WITH THE RETAIN SAMPLE TEST RESULTS. BASED ON A REVIEW OF BATCH RECORDS AND THE INVESTIGATION RESULTS, NO ROOT CAUSE FROM THE MANUFACTURING PROCESS HAS BEEN IDENTIFIED AS A CONTRIBUTOR TO THE UNDERFILL. THE DEVICE HISTORY RECORD WAS REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. BD IS ABLE TO CONFIRM THE CUSTOMERS REPORTED DEFECT. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT AFFECTED 197 TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE END USER REPORTS THAT 6,8% OF TUBES ARE FAILING, THERE IS NO VACUUM AND CANNOT DRAW PROPERLY".

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT AFFECTED 197 TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE END USER REPORTS THAT 6,8% OF TUBES ARE FAILING, THERE IS NO VACUUM AND CANNOT DRAW PROPERLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274752 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367988 SEE H.10 50382903679886

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown