BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES

    MDR report key: 19542541 · Received June 14, 2024

    Report

    Report Number
    1917413-2024-00532
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    May 17, 2024
    Report Date
    July 11, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    GIM
    UDI-DI
    30382903678564
    PMA / PMN Number
    BK230980
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MATERIAL #: 367856. LOT/BATCH #: 2292067, 3111807, 3136158, 3163670. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 100 RETENTION SAMPLES FOR EACH LOT FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO SAMPLE QUALITY 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. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF (B)(6) 2024. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. 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 SAMPLE QUALITY. 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

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES: D2B: MEDICAL DEVICE TYPE: JKA THERE WERE MULTIPLE 510K NUMBERS G5. PMA / 510(K)#: K213670, K231373 THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 2292067 D4. MEDICAL DEVICE EXPIRATION DATE: 29-FEB-2024 H4. DEVICE MANUFACTURE DATE: 19-OCT-2022 D4. MEDICAL DEVICE LOT #: 3111807 D4. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2024 H4. DEVICE MANUFACTURE DATE: 19-OCT-2022 D4. MEDICAL DEVICE LOT #: 3136158 D4. MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2024 H4. DEVICE MANUFACTURE DATE: 19-OCT-2022 H3. 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 AFTER BLOOD COLLECTION THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES WERE CLOTTING. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER BLOOD COLLECTION THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES WERE CLOTTING. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766991 BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE GIM BECTON, DICKINSON & CO. (BROKEN BOW) 3163670 30382903678564

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown