BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 17560307 · Received August 16, 2023

    Report

    Report Number
    9617032-2023-01104
    Event Type
    Malfunction
    Date Received
    August 16, 2023
    Date of Event
    August 4, 2023
    Report Date
    November 3, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679558
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: MATERIAL #: 367955; LOT/BATCH #: 2256251,2265048, AND 3010284. BD HAD NOT RECEIVED SAMPLES, BUT 4 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED, AND THE INDICATED FAILURE MODE OF GEL SMEARING WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, THE INDICATED FAILURE MODE FOR OIL GEL GLOBULES WAS OBSERVED. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES EXHIBITED PROPER FILL. BD WAS ABLE TO DUPLICATE THE CUSTOMER¿S INDICATED FAILURE MODE (OIL GEL GLOBULES) BECAUSE THE DEFECT WAS EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. REPLICATES OF RETENTION SAMPLES OF LOTS 2256251 AND 2265048 SHOWED A DEGREE OF THE DEFECT BUT TESTING FOR LOT 3010284 WAS WITHIN SPECIFICATION. ALL OTHER VISUAL OBSERVATIONS OF BOTH RETAIN AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. 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 GEL SMEARING FOR ALL LOTS. THIS COMPLAINT IS CONFIRMED WITH RESPECT TO OIL GEL GLOBULES FOR LOTS 2256251 AND 2265048. 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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES THAT THERE WERE OIL GEL GLOBULES SEEN IN A LARGE QUANTITY OF TUBES ACROSS 3 DIFFERNT LOT NUMBERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: YELLOW TUBE 367955 LARGE FLOATING OIL, THE INSTRUMENT BLOCKED THE NEEDLE, THE MACHINE ALARM, UNABLE TO PRODUCE A TEST REPORT, CURRENTLY CONSIDERING THE REPLACEMENT OF THE GOODS NUMBER.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 2256251. D4. MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. H4. DEVICE MANUFACTURE DATE: 2022-09-13. D4. MEDICAL DEVICE LOT #: 2265048. D4. MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. H4. DEVICE MANUFACTURE DATE: 2022-09-22. D4. MEDICAL DEVICE LOT #: 3010284. D4. MEDICAL DEVICE EXPIRATION DATE: 2024-07-31. H4. DEVICE MANUFACTURE DATE: 2023-01-10. H.3. 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 THAT WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES THAT THERE WERE OIL GEL GLOBULES SEEN IN A LARGE QUANTITY OF TUBES ACROSS 3 DIFFERENT LOT NUMBERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: YELLOW TUBE 367955 LARGE FLOATING OIL, THE INSTRUMENT BLOCKED THE NEEDLE, THE MACHINE ALARM, UNABLE TO PRODUCE A TEST REPORT, CURRENTLY CONSIDERING THE REPLACEMENT OF THE GOODS NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES THAT THERE WERE OIL GEL GLOBULES SEEN IN A LARGE QUANTITY OF TUBES ACROSS 3 DIFFERNT LOT NUMBERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: YELLOW TUBE 367955 LARGE FLOATING OIL, THE INSTRUMENT BLOCKED THE NEEDLE, THE MACHINE ALARM, UNABLE TO PRODUCE A TEST REPORT, CURRENTLY CONSIDERING THE REPLACEMENT OF THE GOODS NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES THAT THERE WAS GEL SMEARING IN 3 DIFFERENT TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: YELLOW TUBE 367955 LARGE FLOATING OIL, THE INSTRUMENT BLOCKED THE NEEDLE, THE MACHINE ALARM, UNABLE TO PRODUCE A TEST REPORT, CURRENTLY CONSIDERING THE REPLACEMENT OF THE GOODS NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1906062 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10 50382903679558

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown