BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SERUM BLOOD COLLECTION TUBES

    MDR report key: 17466765 · Received August 4, 2023

    Report

    Report Number
    1024879-2023-00538
    Event Type
    Malfunction
    Date Received
    August 4, 2023
    Date of Event
    July 18, 2023
    Report Date
    August 30, 2023
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903678209
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2139033. D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-05-31. H.4. DEVICE MANUFACTURE DATE: 2022-05-19. D.4. MEDICAL DEVICE LOT #: 2348951. D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-12-31. H.4. DEVICE MANUFACTURE DATE: 2022-12-14. D.4. MEDICAL DEVICE LOT #: 3170988. D.4. MEDICAL DEVICE EXPIRATION DATE: 2025-06-30. H.4. DEVICE MANUFACTURE DATE: 2023-06-19.

    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: 15-AUG-2023. H6: INVESTIGATION SUMMARY: MATERIAL #: 367820. LOT/BATCH #: 2139033, 2348951, 3170988. BD RECEIVED A TOTAL OF 30 SAMPLES (10 FROM EACH LOT) FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER/CONDENSATION WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 30 RETENTION SAMPLES FROM BD INVENTORY FROM EACH LOT WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO FOREIGN MATTER/CONDENSATION AS ALL SAMPLES MET SPECIFICATIONS. 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 THE INDICATED FAILURE MODE FOREIGN MATTER. 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® SERUM BLOOD COLLECTION TUBES REPORTED BY THE CUSTOMER THAT REPORTS CONDENSATION/MOISTURE INSIDE THE TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT REPORTS CONDENSATION/MOISTURE INSIDE THE TUBES. LOT #S 2139033, 2348951, 3170988.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES REPORTED BY THE CUSTOMER THAT REPORTS CONDENSATION/MOISTURE INSIDE THE TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT REPORTS CONDENSATION/MOISTURE INSIDE THE TUBES. LOT #S 2139033, 2348951, 3170988.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1814319 BD VACUTAINER® SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) SEE H.10 50382903678209

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown