BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 17234697 · Received June 29, 2023

    Report

    Report Number
    9617032-2023-00818
    Event Type
    Malfunction
    Date Received
    June 29, 2023
    Date of Event
    June 16, 2023
    Report Date
    August 14, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. E.1. INITIAL REPORTER ADDRESS: (B)(6). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2203590. D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-01-31. H.4. DEVICE MANUFACTURE DATE: 2022-07-22. D.4. MEDICAL DEVICE LOT #: 2245728. D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-02-29. H.4. DEVICE MANUFACTURE DATE: 2022-09-02. D.4. MEDICAL DEVICE LOT #: 2263067. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    LOT AND EXPIRATION/ MANUFACTURE DATE HAS BEEN UPDATED IN D.4 AND H.4. H.6 INVESTIGATION SUMMARY: BD RECEIVED 5 PHOTOGRAPHS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. 1 PHOTOGRAPH INDICATED 4 TUBES, IT WAS OBSERVED THAT SERUM WAS CLOUDY. NO CONCLUSIONS CAN BE DRAWN FROM THE PHOTOS AS ERRONEOUS RESULTS CANNOT BE EVALUATED THROUGH PHOTOS. RETENTION SAMPLES FROM BD INVENTORY WERE VISUALLY INSPECTED WITH NO ISSUES IDENTIFIED. CERTAIN ASSAYS, IN THIS CASE HEPATITIS TESTING, ARE EXCLUDED FROM OUR PROTOCOLS. THEREFORE, WE ARE AT THE PRESENT TIME, UNABLE TO PERFORM INTERNAL TESTING FOR INFECTIOUS DISEASES. 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. A COMPLAINT HISTORY REVEALED THIS IS THE ONLY COMPLAINT RECEIVED ON THIS BATCH FOR THE REPORTED DEFECT (ERRONEOUS RESULTS). THIS COMPLAINT IS NOT CONFIRMED WITH RESPECT TO ERRONEOUS RESULTS-HBSAG. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES HAVE VARYING RESULTS WITH DIFFERENT LOT. THIS EVENT OCCURRED 1500 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ONE PATIENT SAMPLE SST GEL TUBE LOT NO-2203590 IS REPORT REACTIVE FOR HBSAG AND AGAIN THEY HAVE RECOLLECTED THE SAMPLE WITH SST GEL TUBE WITH DIFFERENT LOT NO-2245728 REPORTED NEGATIVE AND THEY WANT TO CROSS VERIFY THE REPORT AGAIN THEY HAVE COLLECTED THE SAMPLE WITH GEL TUBE LOT NO-2203590 REPORTED NEGATIVE SO THEY WANT TO CROSS VERIFY THE REPORT AGAIN THEY HAVE COLLECTED THE FRESH SAMPLE WITH PLAIN TUBE LOT NO-2263067 SO THIS SAMPLE REPORTED NEGATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES HAVE VARYING RESULTS WITH DIFFERENT LOT. THIS EVENT OCCURRED 1500 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ONE PATIENT SAMPLE SST GEL TUBE LOT NO-2203590 IS REPORT REACTIVE FOR HBSAG AND AGAIN THEY HAVE RECOLLECTED THE SAMPLE WITH SST GEL TUBE WITH DIFFERENT LOT NO-2245728 REPORTED NEGATIVE AND THEY WANT TO CROSS VERIFY THE REPORT AGAIN THEY HAVE COLLECTED THE SAMPLE WITH GEL TUBE LOT NO-2203590 REPORTED NEGATIVE SO THEY WANT TO CROSS VERIFY THE REPORT AGAIN THEY HAVE COLLECTED THE FRESH SAMPLE WITH PLAIN TUBE LOT NO-2263067 SO THIS SAMPLE REPORTED NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1822610 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2203590

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown