BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 20213671 · Received September 13, 2024

    Report

    Report Number
    9617032-2024-01459
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    August 15, 2024
    Report Date
    October 15, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    30382903679547
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT THREE (3) PHOTOS AND ONE (1) VIDEO WERE PROVIDED FOR INVESTIGATION. BOTH THE PHOTOS AND THE VIDEO WERE REVIEWED AND THE INDICATED FAILURE MODE FOR GEL GLOBULES IN THE SERUM, FIBRIN STRAND AND POOR BARRIER SEPARATION WERE OBSERVED. ADDITIONALLY, 100 RETAINED SAMPLES WERE VISUALLY INSPECTED, AND NO GEL DEFECTS OR ADDITIVE ABNORMALITY WAS FOUND. COMPLAINTS FOR SAMPLE QUALITY FOR THE MONTH OF AUGUST 2024 WERE NOT UNDER STATISTICAL CONTROL THEREFORE FACTORS THAT MAY CONTRIBUTE TO OIL GEL GLOBULES, FIBRIN STRAND AND POOR BARRIER SEPARATION 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 MODES, FIBRIN, POOR BARRIER SEPARATION AND OIL GEL GLOBULES, VIA CLINICAL INVESTIGATION BECAUSE THE DEFECTS WERE NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. ALL VISUAL OBSERVATIONS OF BOTH RETENTION 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 THE INDICATED FAILURE MODE OF OIL GEL GLOBULES, FIBRIN STRAND AND POOR BARRIER SEPARATION BASED ON THE PHOTO AND VIDEO ANALYSIS. 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

    E1: INITIAL REPORTER CITY: ADDITIONAL NAME APPLIES: (B)(6). INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 3 PHOTOS AND 1 VIDEO WERE PROVIDED FOR INVESTIGATION. THE PHOTOS AND THE VIDEO WERE REVIEWED AND THE INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION, FIBRIN AND OIL GEL GLOBULES WERE OBSERVED. ADDITIONALLY, 100 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO GEL ISSUE OR ADDITIVE ABNORMALITY WAS OBSERVED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF AUGUST 2024. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. 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 POOR BARRIER SEPARATION, FIBRIN AND OIL GEL GLOBULES. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE, HOWEVER, IT IS UNDERSTOOD THAT PATIENT CONDITIONS, TUBE STORAGE AND PROCESSING CONDITIONS, AND CENTRIFUGATION SETTINGS, CAN IMPACT ON THE QUALITY OF THE SERUM. 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 DURING THE USE OF BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, THE CUSTOMER OBSERVED SAMPLE QUALITY ISSUES CAUSING FREQUENT S1 PROBE ALARMS ON (10) TUBES. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE USE OF BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, THE CUSTOMER OBSERVED SAMPLE QUALITY ISSUES CAUSING FREQUENT S1 PROBE ALARMS ON (10) TUBES. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208010 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 4072646 30382903679547

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown