BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 9537299 · Received January 2, 2020

    Report

    Report Number
    9617032-2019-01588
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 16, 2019
    Report Date
    March 25, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. A BD REPRESENTATIVE PROVIDED TROUBLESHOOTING WITH THE CUSTOMER. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES HAD MORE "FIBRINS AND STRANDS" IN THE GEL DURING USE THAN NORMAL, AFTER THE CENTRIFUGATION WAS PERFORMED. TUBES WERE STORED IN A "COOL ROOM WITH VENTILATION" PRIOR TO USE, WITH "NO DIRECT SUNLIGHT AND WINDOWS". THEY WERE CENTRIFUGED ON "1500G AT 10 MIN" WITH "PROPER MIXING, MINIMUM 30 MIN VERTICALLY WAITING". BLOOD WAS COAGULATED "PROPERLY BEFORE CENTRIFUGE", BUT FIBRIN STANDS AND "DIRTY GEL" WAS STILL DETECTED, WITH THE GEL BEING "SPREAD" IN SOME CASES. LOT #'S 9036950 AND 9106811 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "- GEL HAS FIBRINS AND STRANDS IN IT AFTER CENTRIFUGATIONS MORE THEN USUAL. CENTRIFUGATION SETTINGS ARE 1500G AT 10 MIN, THE DEVICE HAS BEEN CALIBRATING AT 11/2019. -PROPER STORAGE CONDITIONS PRIOR USE: COOL ROOM WITH VENTILATION, NO DIRECT SUNLIGHT AND WINDOWS WITH AWNINGS ON THE WINDOWS." "PRIOR AND AFTER BLOOD COLLECTIONS ¿ TUBES DID NOT EXPOSED TO EXTREME TEMP'. -BLOOD WAS COAGULATE PROPERLY BEFORE CENTRIFUGE (PROPER MIXING , MINIMUM 30 MIN VERTICALLY WAITING( - BUT STEEL FIBRINES AND DIRTY GEL WERE DETECTED, COSTUMER SAID THAT IN SOME CASES THE GEL WAS SPREAD."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9036950. MEDICAL DEVICE EXPIRATION DATE: 2020-08-31. DEVICE MANUFACTURE DATE: 2019-02-05. MEDICAL DEVICE LOT #: 9106811. MEDICAL DEVICE EXPIRATION DATE: 2020-10-31. DEVICE MANUFACTURE DATE: 2019-04-16. 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 · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES HAD MORE "FIBRINS AND STRANDS" IN THE GEL DURING USE THAN NORMAL, AFTER THE CENTRIFUGATION WAS PERFORMED. TUBES WERE STORED IN A "COOL ROOM WITH VENTILATION" PRIOR TO USE, WITH "NO DIRECT SUNLIGHT AND WINDOWS". THEY WERE CENTRIFUGED ON "1500G AT 10 MIN" WITH "PROPER MIXING, MINIMUM 30 MIN VERTICALLY WAITING". BLOOD WAS COAGULATED "PROPERLY BEFORE CENTRIFUGE", BUT FIBRIN STANDS AND "DIRTY GEL" WAS STILL DETECTED, WITH THE GEL BEING "SPREAD" IN SOME CASES. LOT #'S 9036950 AND 9106811 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "- GEL HAS FIBRINS AND STRANDS IN IT AFTER CENTRIFUGATIONS MORE THEN USUAL. -CENTRIFUGATION SETTINGS ARE 1500G AT 10 MIN, THE DEVICE HAS BEEN CALIBRATING AT 11/2019. -PROPER STORAGE CONDITIONS PRIOR USE: COOL ROOM WITH VENTILATION, NO DIRECT SUNLIGHT AND WINDOWS WITH AWNINGS ON THE WINDOWS." "-PRIOR AND AFTER BLOOD COLLECTIONS ¿ TUBES DID NOT EXPOSED TO EXTREME TEMP'. -BLOOD WAS COAGULATE PROPERLY BEFORE CENTRIFUGE (PROPER MIXING , MINIMUM 30 MIN VERTICALLY WAITING( - BUT STEEL FIBRINES AND DIRTY GEL WERE DETECTED, COSTUMER SAID THAT IN SOME CASES THE GEL WAS SPREAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4982 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other