BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 12957196 · Received December 7, 2021

    Report

    Report Number
    1024879-2021-00844
    Event Type
    Malfunction
    Date Received
    December 7, 2021
    Date of Event
    November 10, 2021
    Report Date
    January 28, 2022
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. THEREFORE, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO UNDERFILL OR FIBRIN WERE OBSERVED. 20 RETAIN SAMPLES FOR LOT 1200908 WERE SUBJECTED TO A DRAW TEST FOR LOW OR NO DRAW. ALL TUBES WERE WITHIN SPECIFICATION. 20 RETAIN SAMPLES FOR LOT 1266309 WERE SUBJECTED TO A DRAW TEST FOR LOW OR NO DRAW. ALL TUBES WERE WITHIN SPECIFICATION. 20 RETAIN SAMPLES FOR LOT 1280206 WERE SUBJECTED TO A DRAW TEST FOR LOW OR NO DRAW. ALL TUBES WERE WITHIN SPECIFICATION. NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE, UNDERFILL AND FIBRIN/FIBRIN CLOTS BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. REPLICATES OF BOTH RETAIN AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. ALL TUBES PERFORMED AS EXPECTED. 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 IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE UNDERFILL OR FIBRIN. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. LOT #: UNKNOWN (PROVIDED 1230984) DOES NOT EXIST FOR 367986. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1200908. MEDICAL DEVICE EXPIRATION DATE: 2022-07-31. DEVICE MANUFACTURE DATE: 2021-07-19. MEDICAL DEVICE LOT #: 1266309. MEDICAL DEVICE EXPIRATION DATE: 2022-09-30. DEVICE MANUFACTURE DATE: 2021-09-23. MEDICAL DEVICE LOT #: 1280206. MEDICAL DEVICE EXPIRATION DATE: 2022-09-30. DEVICE MANUFACTURE DATE: 2021-10-07. 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¿ BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD, MISSING ADDITIVE. . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: MATERIAL NO: 367986 BATCH NO: 1200908, 1266309, 1280206 AND UNKNOWN (PROVIDED 1230984). IT WAS REPORTED THAT THE TUBES ARE NOT FILLING PROPERLY AND THERE ARE FIBRIN STRANDS. I TRIED TO CALL HER BUT GOT HER ANSWERING MACHINE SO I LEFT A VOICE MESSAGE ASKING HER TO CALL ME BACK SO I CAN GET ADDITIONAL INFORMATION ABOUT THE PERCEIVED PROBLEMS WITH BOTH VACUUM AND CLOT ACTIVATION. I JUST GOT A CALL BACK FROM DR. (OMITTED). SHE SAID 1 OUT OF EVERY 4 OR 5 SST TUBES IS ONLY FILLING TO ABOUT 50% OF THE STATED 5 ML VOLUME. SHE ALSO SAID THAT AFTER CENTRIFUGATION THEY SEE MULTIPLE FIBRIN STRANDS ABOVE THE GEL SEPARATOR; THE TUBES ARE BEING COLLECTED BY LAB PHLEBOTOMISTS SO SHE IS CONFIDENT THEY ARE BEING INVERTED PROPERLY AFTER COLLECTION. THEY ALLOW THE SST TUBES TO SIT FOR ABOUT 30 MINUTES AFTER THEY ARE RECEIVED IN THE LAB; SHE HAS SEVERAL PHOTOS OF THE FIBRIN STRANDS IN THE CENTRIFUGED TUBES AND WILL PROVIDE COPIES AFTER SHE RECEIVES YOUR EMAIL. (OMITTED), CAN YOU ORDER HER A BOX OR TWO OF THE #367977 4.0 ML SST TUBES? THEY ARE THE SAME 13 X 100MM SIZE AS THE 5.0 ML TUBES THEY ROUTINELY USE, SO THEY¿LL FIT IN HER CENTRIFUGES. I¿LL ALSO GIVE THE SKU TO (OMITTED) AND (OMITTED) IN THEIR PURCHASING DEPARTMENT. IT SEEMS THAT THE LOT 1230963 IS WORKING BETTER THAN LOTS 1200908, 1230984 AND 1266309. WE HAVE SOME OF THESE LEFT- CAN WE GET EITHER REPLACEMENTS OR REIMBURSEMENT FOR THE UNUSED LOTS? CX HAS SOME OF THE 1266309 IN HER OFFICE. AND HOW DO WE GO FORWARD MAKING SURE WE GET LOTS THAT WORK? AND I SUPPOSE WE SHOULD TRY LOT 1253776 BEFORE WE NEED IT AND IT DOESN¿T WORK.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD, MISSING ADDITIVE. . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: MATERIAL NO: 367986 BATCH NO: 1200908, 1266309, 1280206 AND UNKNOWN (PROVIDED 1230984) IT WAS REPORTED THAT THE TUBES ARE NOT FILLING PROPERLY AND THERE ARE FIBRIN STRANDS. I TRIED TO CALL HER BUT GOT HER ANSWERING MACHINE SO I LEFT A VOICE MESSAGE ASKING HER TO CALL ME BACK SO I CAN GET ADDITIONAL INFORMATION ABOUT THE PERCEIVED PROBLEMS WITH BOTH VACUUM AND CLOT ACTIVATION. I JUST GOT A CALL BACK FROM DR. (OMITTED). SHE SAID 1 OUT OF EVERY 4 OR 5 SST TUBES IS ONLY FILLING TO ABOUT 50% OF THE STATED 5 ML VOLUME. SHE ALSO SAID THAT AFTER CENTRIFUGATION THEY SEE MULTIPLE FIBRIN STRANDS ABOVE THE GEL SEPARATOR; THE TUBES ARE BEING COLLECTED BY LAB PHLEBOTOMISTS SO SHE IS CONFIDENT THEY ARE BEING INVERTED PROPERLY AFTER COLLECTION. THEY ALLOW THE SST TUBES TO SIT FOR ABOUT 30 MINUTES AFTER THEY ARE RECEIVED IN THE LAB; SHE HAS SEVERAL PHOTOS OF THE FIBRIN STRANDS IN THE CENTRIFUGED TUBES AND WILL PROVIDE COPIES AFTER SHE RECEIVES YOUR EMAIL. (OMITTED), CAN YOU ORDER HER A BOX OR TWO OF THE #367977 4.0 ML SST TUBES? THEY ARE THE SAME 13 X 100MM SIZE AS THE 5.0 ML TUBES THEY ROUTINELY USE, SO THEY¿LL FIT IN HER CENTRIFUGES. I¿LL ALSO GIVE THE SKU TO (OMITTED) AND (OMITTED) IN THEIR PURCHASING DEPARTMENT. IT SEEMS THAT THE LOT 1230963 IS WORKING BETTER THAN LOTS 1200908, 1230984 AND 1266309. WE HAVE SOME OF THESE LEFT- CAN WE GET EITHER REPLACEMENTS OR REIMBURSEMENT FOR THE UNUSED LOTS? CX HAS SOME OF THE 1266309 IN HER OFFICE. AND HOW DO WE GO FORWARD MAKING SURE WE GET LOTS THAT WORK? AND I SUPPOSE WE SHOULD TRY LOT 1253776 BEFORE WE NEED IT AND IT DOESN¿T WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1854851 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367986 SEE H.10 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown