BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17410627 · Received July 27, 2023

    Report

    Report Number
    2243072-2023-01319
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    July 6, 2023
    Report Date
    October 25, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    UDI-DI
    50382903687744
    PMA / PMN Number
    K101502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED: DEVICE AVAILABLE FOR EVAL? YES RETURNED TO MANUFACTURER ON 12SEP2023. INVESTIGATION SUMMARY. MATERIAL #: 368774 LOT/BATCH #: 230104 BD RECEIVED 16 SAMPLES FOR INVESTIGATION. THE SAMPLES 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 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 ERRONEOUS RESULTS. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS OEM SEKISUI. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1., AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER, H.3. 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 THAT WHILE USING THE BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. 1) HOW MANY INVERSIONS ARE DONE TO THE SAMPLE AFTER COLLECTION? TWO DISCREPANT READINGS OCCUR WITH REPEAT MEASUREMENTS FROM THE IDENTICAL TUBE. THE REPRODUCIBILITY OF THE VALUES IS NOT GIVEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. 1) HOW MANY INVERSIONS ARE DONE TO THE SAMPLE AFTER COLLECTION? TWO. DISCREPANT READINGS OCCUR WITH REPEAT MEASUREMENTS FROM THE IDENTICAL TUBE. THE REPRODUCIBILITY OF THE VALUES IS NOT GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2326480 BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON 230104 50382903687744

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown