BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 9538481 · Received January 2, 2020

    Report

    Report Number
    1024879-2019-02212
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 17, 2019
    Report Date
    March 24, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679886
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY BD RECEIVED SAMPLES AND PHOTOS FROM 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. ADDITIONALLY, EVALUATION OF THE CUSTOMER SAMPLES WAS PERFORMED AND NO DEFECTS WERE 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. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD "HOLES" IN THE GEL DURING USE, AND CELLS ABOVE THE GEL, ON TOP OF THE SERUM, AND ON THE SIDES OF THE TUBE. AS A RESULT, ALL TUBES WERE REJECTED. THE TUBES WERE ALLOWED TO CLOT FOR "20 MINUTES" AND SPUN IN A "LAB CORP CENTRIFUGE" AT "3375 RPM FOR 10-15 MINUTES". LOT #'S 9246601, 9263408, AND 9270138 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THIS COMPLAINT WAS CREATED TO CAPTURE THE (B)(4) OF (B)(4) 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SHE STATES THEY HAVE BEEN HAVING THIS ISSUE FOR 2 MONTHS. THE SST TUBES ARE ALLOWED TO CLOT FOR 20 MINUTES AND SPUN IN A LAB CORP CENTRIFUGE, WHICH IS SET AT 3375 RPM FOR 10-15 MINUTES. THE SETTINGS CANNOT BE CHANGED. THE CENTRIFUGE IS CALIBRATED ONCE/YEAR, AND IS DUE IN JUNE 2020. THE CUSTOMER STATES THAT THERE ARE HOLES IN THE GEL, AND CELLS GET ABOVE THE GEL, AND ALSO ON THE SIDES OF THE TUBE AND ON TOP OF THE SERUM. THE TUBES ARE BEING REJECTED." "THE HAVE BEEN HAVING DAILY OCCURRENCES OF POOR SEPARATION FOR ALMOST A TWO MONTHS. THE SAMPLES ARE SPUN FOR 10 TO 15 MINUTES AND SENT TO THE LAB AND THE SPECIMENS ARE REJECTED."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9246601. MEDICAL DEVICE EXPIRATION DATE: 2020-08-31. DEVICE MANUFACTURE DATE: 2019-09-03. MEDICAL DEVICE LOT #: 9263408. MEDICAL DEVICE EXPIRATION DATE: 2020-09-30. DEVICE MANUFACTURE DATE: 2019-09-20. MEDICAL DEVICE LOT #: 9270138. MEDICAL DEVICE EXPIRATION DATE: 2020-09-30. DEVICE MANUFACTURE DATE: 2019-09-27. 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¿ BLOOD COLLECTION TUBES HAD "HOLES" IN THE GEL DURING USE, AND CELLS ABOVE THE GEL, ON TOP OF THE SERUM, AND ON THE SIDES OF THE TUBE. AS A RESULT, ALL TUBES WERE REJECTED. THE TUBES WERE ALLOWED TO CLOT FOR "20 MINUTES" AND SPUN IN A "LAB CORP CENTRIFUGE" AT "3375 RPM FOR 10-15 MINUTES". LOT #'S 9246601, 9263408, AND 9270138 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SHE STATES THEY HAVE BEEN HAVING THIS ISSUE FOR 2 MONTHS. THE SST TUBES ARE ALLOWED TO CLOT FOR 20 MINUTES AND SPUN IN A LAB CORP CENTRIFUGE, WHICH IS SET AT 3375 RPM FOR 10-15 MINUTES. THE SETTINGS CANNOT BE CHANGED. THE CENTRIFUGE IS CALIBRATED ONCE/YEAR, AND IS DUE IN JUNE 2020. THE CUSTOMER STATES THAT THERE ARE HOLES IN THE GEL, AND CELLS GET ABOVE THE GEL, AND ALSO ON THE SIDES OF THE TUBE AND ON TOP OF THE SERUM. THE TUBES ARE BEING REJECTED." "THE HAVE BEEN HAVING DAILY OCCURRENCES OF POOR SEPARATION FOR ALMOST A TWO MONTHS. THE SAMPLES ARE SPUN FOR 10 TO 15 MINUTES AND SENT TO THE LAB AND THE SPECIMENS ARE REJECTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4680 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367988 SEE SECTION H.10. 50382903679886

    Patients

    Seq Age Sex Outcome Treatment
    1 Other