BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES

    MDR report key: 23513578 · Received November 10, 2025

    Report

    Report Number
    1917413-2025-01519
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 13, 2025
    Report Date
    October 16, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    GIM
    UDI-DI
    30382903678618
    PMA / PMN Number
    BK230980
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES: D2B: MEDICAL DEVICE TYPE: JKA. THERE WERE MULTIPLE 510K NUMBERS G4: PMA / 510(K)#: K213670, K231373. INVESTIGATION SUMMARY: BD RECEIVED THREE PHOTOS FOR INVESTIGATION, WHICH SHOW A PIECE OF PLASTIC PROTRUDING FROM THE GATE ON THE HEMOGARD CLOSURE. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: MOLDING DEFECT. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES, THERE WERE 119 TUBES THAT HAVE SHARP PROTRUSIONS ON THE HEMOGARD CAP. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1877997 BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE GIM BECTON, DICKINSON & CO. (BROKEN BOW) 5048307 30382903678618

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown