BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® VENOUS BLOOD COLLECTION TUBE SERUM

    MDR report key: 17878043 · Received October 5, 2023

    Report

    Report Number
    2243072-2023-01797
    Event Type
    Malfunction
    Date Received
    October 5, 2023
    Date of Event
    September 12, 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

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS 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. B.3. 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: D.4. MEDICAL DEVICE LOT #: 221104. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2024. H.4. DEVICE MANUFACTURE DATE: 02-MAY-2023. . D.4. MEDICAL DEVICE LOT #: 230201. D.4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2024. H.4. DEVICE MANUFACTURE DATE: 12-MAY-12023. D.4. MEDICAL DEVICE LOT #: 221006. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2023. H.4. DEVICE MANUFACTURE DATE: 14-MAR-2023.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED. D.10. DEVICE AVAILABLE FOR EVAL? YES. D.10. RETURNED TO MANUFACTURER ON 21SEP2023. H.6. INVESTIGATION SUMMARY: MATERIAL #: 368774. LOT/BATCH #: 221104, 230201, AND 221006. BD RECEIVED 4 SAMPLES (2 FROM LOT 221104, 1 FROM LOT 221006, AND 1 FROM LOT 230201) FOR INVESTIGATION. THE SAMPLES ALONG WITH RETENTION TUBES FROM THE SAME REPORTED LOT NUMBERS 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® VENOUS BLOOD COLLECTION TUBE SERUM HAD ERRONEOUS RESULTS. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: I SENT AN EMAIL YESTERDAY TO INFORM EMEA PRODUCTCOMPLAINTS THAT THE EARLIEST WE CAN EXPECT AN ANSWER WOULD BE TODAY. THE CUSTOMER INFORMED US THAT ALL THE LOT.NR. 221104, 230201, AND 221006 WERE AFFECTED. THIS COMPLAINT REFERS TO THE CHILD RECORD 8881614 CREATED BY CRAIG HUGHES: I RECEIVED 20 RST TUBES, 16 FROM LOT 230104, 2 FROM LOT 221104, 1 FROM LOT 230201, AND 1 FROM LOT 221006.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® VENOUS BLOOD COLLECTION TUBE SERUM HAD ERRONEOUS RESULTS. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: I SENT AN EMAIL YESTERDAY TO INFORM EMEA PRODUCT COMPLAINTS THAT THE EARLIEST WE CAN EXPECT AN ANSWER WOULD BE TODAY. THE CUSTOMER INFORMED US THAT ALL THE LOT.NR. 221104, 230201, AND 221006 WERE AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2077517 BD VACUTAINER® VENOUS BLOOD COLLECTION TUBE SERUM BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON SEE H.10 50382903687744

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown