BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E (EDTA) 18.0MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 18970082 · Received March 25, 2024

    Report

    Report Number
    9617032-2024-00422
    Event Type
    Malfunction
    Date Received
    March 25, 2024
    Date of Event
    March 1, 2024
    Report Date
    March 8, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    30382903675259
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN . H.4. DEVICE MANUFACTURE DATE: UNKNOWN . LOT NUMBER WAS NOT REPORTED; HOWEVER, POTENTIAL LOT NUMBERS WERE PROVIDED. THE INFORMATION FOR THE LOT NUMBERS ARE AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 4046892. D4. MEDICAL DEVICE EXPIRATION DATE: 01-FEB-2024. H4. DEVICE MANUFACTURE DATE: 31-JAN-2026. D4. MEDICAL DEVICE LOT #: 3282114. D4. MEDICAL DEVICE EXPIRATION DATE: 01-NOV-2023. H4. DEVICE MANUFACTURE DATE: 31-OCT-2025. D4. MEDICAL DEVICE LOT #: 3170111. D4. MEDICAL DEVICE EXPIRATION DATE: 01-JUL-2023. H4. DEVICE MANUFACTURE DATE: 30-JUN-2025. D4. MEDICAL DEVICE LOT #: 3180442. D4. MEDICAL DEVICE EXPIRATION DATE: 01-JUL-2023. H4. DEVICE MANUFACTURE DATE: 30-JUN-2025. H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 7 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR UNDERFILL WAS NOT OBSERVED. IN ADDITION, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® K2E (EDTA) 18.0MG PLUS BLOOD COLLECTION TUBES EXPERIENCED UNDERFILL. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4085 BD VACUTAINER® K2E (EDTA) 18.0MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) UNKNOWN 30382903675259

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown