BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE

    MDR report key: 13690066 · Received March 8, 2022

    Report

    Report Number
    9617032-2022-00186
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    February 24, 2022
    Report Date
    June 9, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL? YES. D9: RETURNED TO MANUFACTURER ON: 29-MAR-2022. H6: INVESTIGATION SUMMARY: BD RECEIVED 12 SAMPLES AND 4 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR GEL BUBBLES AND POOR SERUM WAS OBSERVED. 100 RETENTION SAMPLES WERE VISUALLY INSPECTED, AND NO GEL BUBBLES WERE OBSERVED. 4 RETAINED TUBES FROM THE SAME LOT NUMBER WERE DRAWN WITH HORSE BLOOD, MIXED, STOOD AT ROOM TEMPERATURE FOR 30 MINUTES, BEFORE BEING CENTRIFUGED AT 1300G FOR 10 MINUTES, USING AN MSE MISTRAL 1000 CENTRIFUGE. ALL 4 TUBES WERE FOUND TO HAVE GOOD GEL SEPARATION. 12 SAMPLES WERE RECEIVED FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. VISUAL OBSERVATION ON 12 RETURNED SAMPLES DID CONFIRM GEL AIR BUBBLES. 4 RETURNED TUBES WERE DRAWN WITH HORSE BLOOD, MIXED, STOOD AT ROOM TEMPERATURE FOR 30 MINUTES, BEFORE BEING CENTRIFUGED AT 1300G FOR 10 MINUTES, USING AN MSE MISTRAL 1000 CENTRIFUGE. ALL 4 RETURNED TUBES WERE FOUND TO HAVE GOOD GEL SEPARATION. CLINICAL TESTING WAS PERFORMED TO FURTHER EVALUATE FOR POOR SERUM, POOR BARRIER SEPARATION, AND GEL AIR BUBBLES: THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS NOT ABLE TO DUPLICATE POOR BARRIER SEPARATION OR POOR SERUM BECAUSE THESE DEFECTS WERE NOT EVIDENT IN THE TESTING OF THE RETAINED LOT SAMPLES. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE, GEL BUBBLES, BECAUSE THE DEFECT WAS EVIDENT IN THE TESTING OF THE RETAINED LOT SAMPLES. 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 PHOTOS, RETURNS, AND RETAINS) AND POOR SERUM (BASED ON PHOTOS ONLY). BD WAS UNABLE TO CONFIRM THIS COMPLAINT FOR POOR BARRIER SEPARATION BASED ON THE TESTING PERFORMED. BUBBLES IN GEL - IS A COSMETIC DEFECT WHICH SHOULD NOT IMPACT ON THE EFFICACY OF THE TUBE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE THERE WERE AIR BUBBLES IN THE GEL, POOR BARRIER SEPARATION OF THE SAMPLE, AND POOR SERUM. THE AIR BUBBLE EVENT OCCURRED 10 TIMES. THE POOR BARRIER SEPARATION EVENT OCCURRED 10 TIMES. THE POOR SERUM EVENT OCCURRED 10 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "MANY OF THE TUBES HAD BUBBLES IN THE GEL AND LOOK DEFORMED. THIS ISSUE LEADS TO INCREASED CELLULAR CONTENT IN THE SERUM OF CENTRIFUGED TUBES. THIS ISSUE WAS OBSERVED WHEN SAMPLES WAS DIVIDED INTO ALIQUOTS (MOVE OF SERUM FROM PRIMARY TUBE TO SECONDARY TUBE) AND CENTRIFUGED. THESE DEFECT TUBES THERE IS ALSO ISSUES WITH ERYTHROCYTES COLLECTION IN THE BOTTOM OF THE 2ND TUBES."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE THERE WERE AIR BUBBLES IN THE GEL, POOR BARRIER SEPARATION OF THE SAMPLE, AND POOR SERUM. THE AIR BUBBLE EVENT OCCURRED 10 TIMES. THE POOR BARRIER SEPARATION EVENT OCCURRED 10 TIMES. THE POOR SERUM EVENT OCCURRED 10 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "MANY OF THE TUBES HAD BUBBLES IN THE GEL AND LOOK DEFORMED. THIS ISSUE LEADS TO INCREASED CELLULAR CONTENT IN THE SERUM OF CENTRIFUGED TUBES. THIS ISSUE WAS OBSERVED WHEN SAMPLES WAS DIVIDED INTO ALIQUOTS (MOVE OF SERUM FROM PRIMARY TUBE TO SECONDARY TUBE) AND CENTRIFUGED. THESE DEFECT TUBES THERE IS ALSO ISSUES WITH ERYTHROCYTES COLLECTION IN THE BOTTOM OF THE 2ND TUBES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312016 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 1274534

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown