BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE

    MDR report key: 19824547 · Received July 25, 2024

    Report

    Report Number
    9617032-2024-01117
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    June 26, 2024
    Report Date
    September 28, 2024
    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
    GM
    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 LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 4081858. D4. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2025. H4. DEVICE MANUFACTURE DATE: 21-MAR-2024. D4. MEDICAL DEVICE LOT #: 4043971. D4. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2025. H4. DEVICE MANUFACTURE DATE: 12-FEB-2024. D4. MEDICAL DEVICE LOT #: 4072660. D4. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2025. H4. DEVICE MANUFACTURE DATE: 12-MAR-2024. 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

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, THIRTY (30) RETENTION SAMPLES FROM BD INVENTORY WERE TESTED FOR EACH BATCH AND NO ISSUES WERE OBSERVED RELATING TO CLOSURE SEPARATION 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 OF CLOSURE SEPARATION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE THAT AN UNSPECIFIED NUMBER OF TUBES EXPERIENCED CLOSURE SEPARATION WHEN THE CAP WAS REMOVED BY THE BECKMAN COULTER DXA. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ II ADVANCE THAT AN UNSPECIFIED NUMBER OF TUBES EXPERIENCED CLOSURE SEPARATION WHEN THE CAP WAS REMOVED BY THE BECKMAN COULTER DXA. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357416 BD VACUTAINER® SST¿ II ADVANCE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H11 50382903679534

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown