BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES

    MDR report key: 20988407 · Received December 20, 2024

    Report

    Report Number
    9617032-2024-02060
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    December 9, 2024
    Report Date
    January 9, 2025
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 03-JAN-2025. INVESTIGATION SUMMARY: BD RECEIVED 5 SAMPLES AND 1 PHOTO FOR INVESTIGATION. THE RETURNED SAMPLES AND PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR ADDITIVE ABNORMALITY WAS OBSERVED. EVALUATION OF THE RETURNED SAMPLES AND PHOTO INDICATED A YELLOWISH EDTA CLUMPS IN THE TUBES. DUE TO THE SIZE OF THE DEPOSIT THE ADDITIVE HAS YELLOWED SLIGHTLY ON IRRADIATION. THIS IS RECOGNIZED TO BE AN AESTHETIC DEFECT WITH NO IMPACT ON THE EFFICIENCY OF THE TUBE. ADDITIONALLY, 100 RETENTION SAMPLES FROM BD INVENTORY, WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF ADDITIVE ABNORMALITY WAS 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 ADDITIVE ABNORMALITY. 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

    D2. ADDITIONAL MEDICAL DEVICE TYPE: GIM. G5. MULTIPLE 510K: BK230980, K213670, K231373. 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 PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES THE ADDITIVE WAS DISCOLORED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES THE ADDITIVE WAS DISCOLORED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2062353 BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 4068286

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown