BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN

    MDR report key: 17319901 · Received July 13, 2023

    Report

    Report Number
    2243072-2023-01217
    Event Type
    Malfunction
    Date Received
    July 13, 2023
    Date of Event
    June 13, 2023
    Report Date
    July 14, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    UDI-DI
    50382903687744
    PMA / PMN Number
    K101502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN THIS MDR, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AS DC BE TEMSE IS AN OEM MANUFACTURING SITE. B3: DATE OF EVENT IS UNKNOWN, THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H3. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION IS A CORRECTION REGARDING MANUFACTURER: IN THIS MDR, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AS SEKISUI IS AN OEM MANUFACTURING SITE. H.6. INVESTIGATION SUMMARY: LOT/BATCH #: 221202, 230104 AND UNKNOWN. BD RECEIVED 5 USED SAMPLES FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE FOUND. FURTHER EXAMINATION AND TESTING COULD NOT BE PERFORMED DUE TO THE TUBES BEING USED. ADDITIONALLY, RETENTION SAMPLES FROM BD INVENTORY OF EACH REPORTED LOT NUMBER WERE EVALUATED BY FUNCTIONAL TESTING FOR TROPONIN T VALUES AND THROMBIN STRENGTH (TITER), AND NO ISSUES WERE OBSERVED RELATING TO ERRONEOUS RESULTS AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS 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 ERRONEOUS RESULTS. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN WAS GIVING ERRONEOUS RESULTS ON TROPONIN T ASSAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I¿M WONDERING IF YOU CAN HELP ME. WE USE YOUR RSTS BUT ARE HAVING PROBLEMS WITH OUR TROPONIN T ASSAY, OCCASIONAL PATIENT RESULTS ARE REPEATING VERY POORLY. WE¿VE INVESTIGATED VARIOUS POTENTIAL ISSUES, BUT STILL DO NOT HAVE A ROOT CAUSE. ONE THING WE HAVE NOTICED IS THAT ALL OF THE AFFECTED SAMPLES HAVE BEEN RUN ON RSTS AS OPPOSED TO SSTS, AND WE HAVE NOTICED THE ISSUE FOR THE LAST 5-6WEEKS. HAVE ANY CHANGES OCCURRED WITH PRODUCTION ETC. THAT COULD HAVE POSSIBLY HAD AN IMPACT? THIS IS AN ONGOING ISSUE WHICH WE ARE CONTINUING TO MONITOR. TO DATE WE HAVE HAD 34 INCORRECT RESULTS REPORTED ON 28 DIFFERENT PATIENTS. WE DO BELIEVE THIS IS LIKELY AN ISSUE NOT RELATED TO TUBES NOW HOWEVER. THIS REPORT IS FOR PATIENT 28 OF 28.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN WAS GIVING ERRONEOUS RESULTS ON TROPONIN T ASSAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IM WONDERING IF YOU CAN HELP ME. WE USE YOUR RSTS BUT ARE HAVING PROBLEMS WITH OUR TROPONIN T ASSAY, OCCASIONAL PATIENT RESULTS ARE REPEATING VERY POORLY. WE'VE INVESTIGATED VARIOUS POTENTIAL ISSUES, BUT STILL DO NOT HAVE A ROOT CAUSE. ONE THING WE HAVE NOTICED IS THAT ALL OF THE AFFECTED SAMPLES HAVE BEEN RUN ON RSTS AS OPPOSED TO SSTS, AND WE HAVE NOTICED THE ISSUE FOR THE LAST 5-6WEEKS. HAVE ANY CHANGES OCCURRED WITH PRODUCTION ETC. THAT COULD HAVE POSSIBLY HAD AN IMPACT? THIS IS AN ONGOING ISSUE WHICH WE ARE CONTINUING TO MONITOR. TO DATE WE HAVE HAD 34 INCORRECT RESULTS REPORTED ON 28 DIFFERENT PATIENTS. WE DO BELIEVE THIS IS LIKELY AN ISSUE NOT RELATED TO TUBES NOW HOWEVER. THIS REPORT IS FOR PATIENT 28 OF 28.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333230 BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON 368774 UNKNOWN 50382903687744

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other