BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19578578 · Received June 20, 2024

    Report

    Report Number
    9617032-2024-00941
    Event Type
    Malfunction
    Date Received
    June 20, 2024
    Date of Event
    May 22, 2024
    Report Date
    May 24, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    30382903668817
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE LOT NUMBERS: D4. MEDICAL DEVICE LOT #: 4003719. D4. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2025. H4. DEVICE MANUFACTURE DATE: 03-JAN-2024. D4. MEDICAL DEVICE LOT #: 3313018. D4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2025. H4. DEVICE MANUFACTURE DATE: 09-NOV-2023. D4. MEDICAL DEVICE LOT #: 3339662. D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2025. H4. DEVICE MANUFACTURE DATE: 05-DEC-2023. E1. INITIAL REPORTER PHONE #: (B)(6). INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT TWO (2) PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AN. ADDITIONALLY, TWENTY (B)(6) RETENTION SAMPLES FROM BD INVENTORY OF EACH REPORTED BATCH WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF UNDERFILL 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 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® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES, 5 TUBES UNDERFILLED. THERE WAS NO REPORT OF PATIENT IMPACT. AFFECTED LOTS: 4003719, QTY 3. 3313018, QTY 1. 3339662, QTY 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2155993 BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H11 30382903668817

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown