BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 17121515 · Received June 13, 2023

    Report

    Report Number
    9617032-2023-00707
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Date of Event
    May 17, 2023
    Report Date
    September 13, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903668828
    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

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 4 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR GEL AIRBUBBLES WAS OBSERVED. ADDITIVE ABNORMALITY, GEL SMEARING, AND INSTRUMENT ISSUES COULD NOT BE OBSERVED FROM THE PHOTOS. 200 RETAINED SAMPLES FROM THE BATCH: 2311301 WERE VISUALLY INSPECTED AND NO DEFECTS WERE FOUND FOR ALL INDICATED FAILURES MODE: GEL AIR BUBBLES, ADDITIVE ABNORMALITIES, GEL SMEARING. 200 RETAINED SAMPLES FROM THE BATCH: 2175165 WERE VISUALLY INSPECTED AND 2 TUBES HAD GEL AIRBUBBLES. NO ADDITIVE ABNORMALITIES OR GEL SMEARING WERE FOUND DURING THE INSPECTION. 200 RETAINED SAMPLES FROM THE BATCH: 2203591 WERE VISUALLY INSPECTED AND 8 TUBES HAD GEL AIRBUBBLES. NO ADDITIVE ABNORMALITIES OR GEL SMEARING WERE FOUND DURING THE INSPECTION. 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 INVESTIGATION COMPLETED. BD WAS UNABLE TO CONFIRM THIS COMPLAINT FOR ADDITIVE ABNORMALITY, INSTRUMENT ISSUES, OR GEL SMEARING. 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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES CUSTOMER STATED THAT 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 "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."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES CUSTOMER STATED THAT 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 "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."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1998484 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 366882 2175165 50382903668828

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown