BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE

    MDR report key: 20924593 · Received December 13, 2024

    Report

    Report Number
    9617032-2024-01937
    Event Type
    Malfunction
    Date Received
    December 13, 2024
    Date of Event
    November 15, 2024
    Report Date
    June 12, 2025
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679534
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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#:4072660. D4. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2025. H4. DEVICE MANUFACTURE DATE: 12-MAR-2024. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D4. MEDICAL DEVICE LOT#:4081858. D4. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2025. H4. DEVICE MANUFACTURE DATE: 12-MAR-2024. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D4. MEDICAL DEVICE LOT#:4120071. D4. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2025. H4. DEVICE MANUFACTURE DATE: 29-APR-2024. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D4. MEDICAL DEVICE LOT#: 4149667. D4. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2025. H4. DEVICE MANUFACTURE DATE: 28-MAY-2024. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D4. MEDICAL DEVICE LOT#: 4178486. D4. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2025. H4. DEVICE MANUFACTURE DATE: 26-JUN-2024. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D4. MEDICAL DEVICE LOT#: 4198965. D4. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2026. H4. DEVICE MANUFACTURE DATE: 16-JUL-2024. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, 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. H3: DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 13-DEC-2024. INVESTIGATION SUMMARY; BD RECEIVED 15 SAMPLES ALTOGETHER FOR BATCHES (4072660, 4081858, 4120071, 4149667, 4178486 AND 4198965) AND 3 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR GEL SMEARING WAS OBSERVED, HOWEVER ERRONEOUS RESULTS COULD NOT BE SEEN FROM THE PHOTOS. ADDITIONALLY, 100 RETAINED SAMPLES WERE VISUALLY EXAMINED FOR ADDITIVE ABNORMALITY AND NO GEL DEFECTS WERE OBSERVED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF NOVEMBER 2024. THE CUSTOMER SAMPLES WERE EVALUATED THROUGH CLINICAL TESTING. FACTORS THAT MAY CONTRIBUTE TO GEL SMEARING AND ERRONEOUS RESULTS-TRIGLYCERIDES WERE EVALUATED THROUGH A CLINICAL STUDY TO VERIFY THE DESIGN OF THE DEVICE MET IT¿S INTENDED USE. 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 (GEL SMEARING) VIA CLINICAL INVESTIGATION BECAUSE THE DEFECTS WERE NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. ADDITIONALLY, BD WAS UNABLE TO CONFIRM THE FAILURE MODE ERRONEOUS RESULTS-TRIGLYCERIDES BECAUSE REPLICATES OF BOTH RETENTION AND CONTROL SAMPLES WERE ACCEPTABLE IN TERMS OF BOTH PRECISION AND ACCURACY. ALL VISUAL OBSERVATIONS OF BOTH RETENTION AND CONTROL SAMPLES 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 OF GEL SMEARING BASED ON PHOTO ANALYSIS AND UNCONFIRMED FOR ERRONEOUS RESULTS-TRIGLYCERIDES 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. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿ II ADVANCE BLOOD COLLECTION TUBES, THE GEL DOES NOT SEPARATE PROPERLY AND REMAINS DRAGGED ALONG THE WALL OF THE TUBE AFTER CENTRIFUGATION ON UNSPECIFIED NUMBER OF TUBES FOR SEVEN (7) BATCHES. THEREFORE, THE SITUATION HAS CREATED PROBLEMS WITH INCREASES IN ANALYTICAL PARAMETERS; THERE HAVE BEEN FALSE VALUES, PARTICULARLY FOR TRIGLYCERIDES. THERE WAS NO FURTHER HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿ II ADVANCE BLOOD COLLECTION TUBES, THE GEL DOES NOT SEPARATE PROPERLY AND REMAINS DRAGGED ALONG THE WALL OF THE TUBE AFTER CENTRIFUGATION ON UNSPECIFIED NUMBER OF TUBES FOR SEVEN (7) BATCHES. THEREFORE, THE SITUATION HAS CREATED PROBLEMS WITH INCREASES IN ANALYTICAL PARAMETERS; THERE HAVE BEEN FALSE VALUES, PARTICULARLY FOR TRIGLYCERIDES. THERE WAS NO FURTHER HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2412619 BD VACUTAINER® SST¿ II ADVANCE TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON, DICKINSON AND COMPANY (BD) 4246202 50382903679534

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown