BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19395158 · Received May 24, 2024

    Report

    Report Number
    9617032-2024-00800
    Event Type
    Malfunction
    Date Received
    May 24, 2024
    Date of Event
    April 26, 2024
    Report Date
    June 20, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903688611
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D4. MEDICAL DEVICE LOT #: 3320922. D4. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2025. H4. DEVICE MANUFACTURE DATE: 16-NOV-2023. D4. MEDICAL DEVICE LOT #: 4003731. D4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2025. H4. DEVICE MANUFACTURE DATE: 03-JAN-2024. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR UNDERFILL WAS OBSERVED. ADDITIONALLY, 40 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING 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 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, 3 TUBES UNDERFILLED. THERE WAS NO REPORT OF PATIENT IMPACT. AFFECTED QUANTITY BY LOT: 3320922, QTY 2. 4003731, QTY 1.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES, 3 TUBES UNDERFILLED. THERE WAS NO REPORT OF PATIENT IMPACT. AFFECTED QUANTITY BY LOT: 3320922, QTY 2. 4003731, QTY 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663492 BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H10 50382903688611

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown