BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18191766 · Received November 22, 2023

    Report

    Report Number
    1917413-2023-01174
    Event Type
    Malfunction
    Date Received
    November 22, 2023
    Date of Event
    November 1, 2023
    Report Date
    December 6, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    00382903678563
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT ONE (1) PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR DAMAGED TUBE WAS OBSERVED. THE INSIDE OF THE USED TUBE HAD AN INDENTATION WHERE PLASTIC WAS PEELED AWAY FROM THE SIDEWALL. NO PHOTOS OF UNUSED TUBES HAVE BEEN RETURNED EXHIBITING THIS DAMAGE. ADDITIONALLY, ONE HUNDRED (100) RETENTION SAMPLES FROM BD INVENTORY OF EACH LOT WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF DAMAGED TUBE WAS NOT OBSERVED. 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 HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE OF DAMAGED TUBE BASED PHOTO ANALYSIS. BD WAS NOT ABLE TO IDENTIFY AN EXACT ROOT CAUSE FOR THE INDICATED FAILURE MODE. BD CAN CONFIRM THAT NOTHING IS INTRODUCED INSIDE THE TUBE DURING MANUFACTURING THAT COULD CAUSE THIS DAMAGE. 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 LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 3163667. D4. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2024. H4. DEVICE MANUFACTURE DATE: 12-JUN-2023. H.3. 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 · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES THAT THE MOLDED PART HAD SHARP PROTRUSIONS, WHICH INHIBITED THE SYSMEX SP-50 FROM PERFORMING A DIFFERENTIAL. NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES THAT THE MOLDED PART HAD SHARP PROTRUSIONS, WHICH INHIBITED THE SYSMEX SP-50 FROM PERFORMING A DIFFERENTIAL. NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1743815 BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 3194745 00382903678563

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown