BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 17130979 · Received June 14, 2023

    Report

    Report Number
    9617032-2023-00715
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Date of Event
    May 17, 2023
    Report Date
    October 10, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679572
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 4 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND GEL AIR BUBBLES WAS OBSERVED. ADDITIVE ABNORMALITY, AND GEL SMEARING WAS NOT OBSERVED. INSTRUMENT ISSUES CANNOT BE EVALUATED THROUGH PHOTOS. 180 RETAINED SAMPLES (LOT 2283470) AND 80 RETAINED SAMPLES (LOT 2245739) WERE VISUALLY INSPECTED, AND 1 OUT OF 180 AND 8 OUT OF 80 SAMPLES HAD BUBBLES IN THE GEL. THIS IS A COSMETIC DEFECT WHICH SHOULD NOT IMPACT THE EFFICACY OF THE TUBE. ADDITIONALLY RETENTION SAMPLES WERE CLINICALLY TESTED: THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AS ALL TUBES EXHIBITED PROPER FILL. BD WAS UNABLE TO DUPLICATE THE CUSTOMER¿S INDICATED FAILURE MODES, GEL SMEARING AND GEL AIR BUBBLES, BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. ALL 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 GEL AIR BUBBLES BASED ON THE PHOTOS PROVIDED AND RETENTION SAMPLE INSPECTION. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR ADDITIVE ABNORMALITY OR GEL SMEARING. INSTRUMENT ISSUES COULD NOT BE EVALUATED AS DESCRIBED IN OUR TESTING. IN THE CUSTOMERS, VERBIAGE WAS NOTED THAT THE CENTRIFUGATION SETTINGS USED ARE NOT RECOMMENDED BY BD. BDS RECOMMENDED SETTINGS ARE 1300G FOR 10 MIN CUSTOMER IS USING 3000G FOR 5 MIN. 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

    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 #: 2245739. D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. H.4. DEVICE MANUFACTURE DATE: 2022-09-02. D.4. MEDICAL DEVICE LOT #: 2283470. D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-04-30. H.4. DEVICE MANUFACTURE DATE: 2022-10-10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES ARE COATED WITH CLOT ACTIVATOR AND GEL AT THE BOTTOM AND UP THE SIDE OF THE TUBES. THERE ARE VERY 'LARGE' 'LUMPS' OF GEL AND CLOT ACTIVATOR ON THE SIDE OF THE TUBES AND 'TONGUES' OF GEL UP THE SIDE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WE HAVE EXPERIENCED THAT THE EQUIPMENT VERY OFTEN (4-5 TIMES AS OFTEN AS BEFORE) MUST HAVE CHANGED MEMBRANES AND ELECTRODES AS WELL AS CHANGE OF PRE-HEATER, WHICH NORMALLY NEVER CHANGED. ERRORS THAT GIVE RISE TO SUSPICION OF "SOILING" OF THE EQUIPMENT. WE HAVE THEREFORE INVESTIGATED WHAT OTHER LABORATORIES USE OF MATERIAL AND THUS PIPE TYPE FOR SIMILAR INVESTIGATIONS ON ABL 825. IS, AMONG OTHER THINGS, THAT THEY ALSO USE SERUM-GEL TUBES, BUT THEY DO NOT EXPERIENCE PROBLEMS. THESE ARE FROM ANOTHER MANUFACTURER THAN BD. THEREFORE, WE HAVE DONE VARIOUS STUDIES ON OUR BD TUBES AND SIMILAR TUBES FROM OTHER MANUFACTURERS, WHICH GIVE US CAUSE FOR CONCERN. IT CONCERNS THE BD SSTTM II ADVANCE (SERUM WITH GEL) TUBE TYPE AND THE FOLLOWING LOT NUMBERS HAVE BEEN EXAMINED, 2203591, 2245739, 2311301, 2283470 AND 2175165. BD'S TUBES ARE COATED WITH CLOT ACTIVATOR AND GEL AT THE BOTTOM AND UP THE SIDE OF THE TUBES. THERE ARE VERY 'LARGE' 'LUMPS' OF GEL AND CLOT ACTIVATOR ON THE SIDE OF THE TUBES AND 'TONGUES' OF GEL UP THE SIDE. THERE ARE IS IN COMPARISON WITH OTHER MANUFACTURER'S SIMILAR TUBE TYPES NOT VISIBLE SPRAY / LUMPS OF GEL AND CLOT ACTIVATOR OR 'TONGUES' OF GEL. WE HAVE EXPERIENCED THAT TUBES HAVE AIR IN THE GEL:"

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES ARE COATED WITH CLOT ACTIVATOR AND GEL AT THE BOTTOM AND UP THE SIDE OF THE TUBES. THERE ARE VERY 'LARGE' 'LUMPS' OF GEL AND CLOT ACTIVATOR ON THE SIDE OF THE TUBES AND 'TONGUES' OF GEL UP THE SIDE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WE HAVE EXPERIENCED THAT THE EQUIPMENT VERY OFTEN (4-5 TIMES AS OFTEN AS BEFORE) MUST HAVE CHANGED MEMBRANES AND ELECTRODES AS WELL AS CHANGE OF PRE-HEATER, WHICH NORMALLY NEVER CHANGED. ERRORS THAT GIVE RISE TO SUSPICION OF "SOILING" OF THE EQUIPMENT. WE HAVE THEREFORE INVESTIGATED WHAT OTHER LABORATORIES USE OF MATERIAL AND THUS PIPE TYPE FOR SIMILAR INVESTIGATIONS ON ABL 825. IS, AMONG OTHER THINGS, THAT THEY ALSO USE SERUM-GEL TUBES, BUT THEY DO NOT EXPERIENCE PROBLEMS. THESE ARE FROM ANOTHER MANUFACTURER THAN BD. THEREFORE, WE HAVE DONE VARIOUS STUDIES ON OUR BD TUBES AND SIMILAR TUBES FROM OTHER MANUFACTURERS, WHICH GIVE US CAUSE FOR CONCERN. IT CONCERNS THE BD SSTTM II ADVANCE (SERUM WITH GEL) TUBE TYPE AND THE FOLLOWING LOT NUMBERS HAVE BEEN EXAMINED, 2203591, 2245739, 2311301, 2283470 AND 2175165. BD'S TUBES ARE COATED WITH CLOT ACTIVATOR AND GEL AT THE BOTTOM AND UP THE SIDE OF THE TUBES. THERE ARE VERY 'LARGE' 'LUMPS' OF GEL AND CLOT ACTIVATOR ON THE SIDE OF THE TUBES AND 'TONGUES' OF GEL UP THE SIDE. THERE ARE IS IN COMPARISON WITH OTHER MANUFACTURER'S SIMILAR TUBE TYPES NOT VISIBLE SPRAY / LUMPS OF GEL AND CLOT ACTIVATOR OR 'TONGUES' OF GEL. WE HAVE EXPERIENCED THAT TUBES HAVE AIR IN THE GEL:".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1956835 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 367957 SEE H.10 50382903679572

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown