BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SERUM BLOOD COLLECTION TUBES

    MDR report key: 8856379 · Received August 2, 2019

    Report

    Report Number
    1024879-2019-01339
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Date of Event
    July 15, 2019
    Report Date
    September 17, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903678209
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR FIBRIN WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION OF THE CUSTOMER SAMPLES WAS PERFORMED AND NO ISSUES 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. BD TECHNICAL SERVICES PROVIDED TROUBLESHOOTING WITH THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® SERUM BLOOD COLLECTION TUBES WERE GIVING ERRONEOUS RESULTS. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367820, BATCH NO. 9031752. IT WAS REPORTED THAT THERE WAS FIBRIN. (2 OF 2: MALE PATIENT). THERE WAS TWO SEPARATE INCIDENTS THAT OCCURRED ON (B)(6) 2019 WITH TWO PATIENTS WITH THE SAME LOT FEMALE SAMPLE WAS SOLID WITH A MILKY WHILE LAYER. MALE SAMPLE WAS SOLID BUT APPEARED TO HAVE A SMALL AMOUNT OF A MUCUS LAYER. SPOKE WITH CUSTOMER AND ONE OF HER CO-WORKERS STATED SHE THOUGHT WHAT THEY WERE SEEING WAS FIBRIN. DISCUSSED WITH CUSTOMER PROPER HANDLING OF SERUM TUBES, MIX 5 TIMES, CLOT 60 MINUTES UPRIGHT, THEN CENTRIFUGE. SITE WILL CONTINUE TO MONITOR ISSUE AND CALL IF PROBLEM PERSISTS OR BECOMES MORE FREQUENT. THE PICTURE SHOWS THE TUBES ON ICE BUT THEY ARE NOT COLLECTED ON ICE OR ALLOWED TO CLOT ON ICE. THEY ARE SPUN AT 4C AS PER THEIR PROTOCOL, SERUM IS REMOVED AND SENT TO A REPOSITORY. THESE 2 SUBJECTS ARE ELDERLY AND IT IS THE FIRST TIME THEY HAVE BEEN DRAWN SO THERE IS NO SPECIMEN TO COMPARE THEM TO. THE PICTURE WHERE THERE IS A SOLID MASS ABOVE THE CELLS, THE MASS APPEARED TO BE SOLID OR GEL LIKE. ADVISED SITE TO MAKE SURE THEY ARE ALLOWED TO CLOT FOR 60 MINUTES PRIOR TO CENTRIFUGATION, IF PATIENTS ON COAG THERAPY THEY MAY TAKE LONGER TO CLOT. COLD WILL IMPEDE THE CLOTTING PROCESS. SPOKE WITH CUSTOMER AND ONE OF HER CO-WORKERS STATED SHE THOUGHT WHAT THEY WERE SEEING WAS FIBRIN. DISCUSSED WITH CUSTOMER PROPER HANDLING OF SERUM TUBES, MIX 5 TIMES, CLOT 60 MINUTES UPRIGHT, THEN CENTRIFUGE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® SERUM BLOOD COLLECTION TUBES WERE GIVING ERRONEOUS RESULTS. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367820 , BATCH NO. 9031752. IT WAS REPORTED THAT THERE WAS FIBRIN. (2 OF 2: MALE PATIENT). THERE WAS TWO SEPARATE INCIDENTS THAT OCCURRED ON (B)(6) 2019 WITH TWO PATIENTS WITH THE SAME LOT FEMALE SAMPLE WAS SOLID WITH A MILKY WHILE LAYER. MALE SAMPLE WAS SOLID BUT APPEARED TO HAVE A SMALL AMOUNT OF A MUCUS LAYER. SPOKE WITH CUSTOMER AND ONE OF HER CO-WORKERS STATED SHE THOUGHT WHAT THEY WERE SEEING WAS FIBRIN. DISCUSSED WITH CUSTOMER PROPER HANDLING OF SERUM TUBES, MIX 5 TIMES, CLOT 60 MINUTES UPRIGHT, THEN CENTRIFUGE. SITE WILL CONTINUE TO MONITOR ISSUE AND CALL IF PROBLEM PERSISTS OR BECOMES MORE FREQUENT. THE PICTURE SHOWS THE TUBES ON ICE BUT THEY ARE NOT COLLECTED ON ICE OR ALLOWED TO CLOT ON ICE. THEY ARE SPUN AT 4C AS PER THEIR PROTOCOL, SERUM IS REMOVED AND SENT TO A REPOSITORY. THESE 2 SUBJECTS ARE ELDERLY AND IT IS THE FIRST TIME THEY HAVE BEEN DRAWN SO THERE IS NO SPECIMEN TO COMPARE THEM TO. THE PICTURE WHERE THERE IS A SOLID MASS ABOVE THE CELLS, THE MASS APPEARED TO BE SOLID OR GEL LIKE. ADVISED SITE TO MAKE SURE THEY ARE ALLOWED TO CLOT FOR 60 MINUTES PRIOR TO CENTRIFUGATION, IF PATIENTS ON COAG THERAPY THEY MAY TAKE LONGER TO CLOT. COLD WILL IMPEDE THE CLOTTING PROCESS. SPOKE WITH CUSTOMER AND ONE OF HER CO-WORKERS STATED SHE THOUGHT WHAT THEY WERE SEEING WAS FIBRIN. DISCUSSED WITH CUSTOMER PROPER HANDLING OF SERUM TUBES, MIX 5 TIMES, CLOT 60 MINUTES UPRIGHT, THEN CENTRIFUGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648109 BD VACUTAINER® SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 9031752 50382903678209

    Patients

    Seq Age Sex Outcome Treatment
    1 Other