BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19580051 · Received June 21, 2024

    Report

    Report Number
    9617032-2024-00947
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    May 21, 2024
    Report Date
    May 24, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    30382903666431
    PMA / PMN Number
    SEE H11
    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

    D2. ADDITIONAL MEDICAL DEVICE TYPE: GIM. G5. ADDITIONAL 510(K): BK230980, K213670, K231373. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. 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 UNDERFILL. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES UNDERFILLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172942 BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3073173 30382903666431

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown