BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K3E 5.4MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 17084202 · Received June 7, 2023

    Report

    Report Number
    9617032-2023-00689
    Event Type
    Malfunction
    Date Received
    June 7, 2023
    Date of Event
    May 10, 2023
    Report Date
    May 23, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 2153625, D4. MEDICAL DEVICE EXPIRATION DATE: 2023-10-31, H4. DEVICE MANUFACTURE DATE: 2022-06-02. D4. MEDICAL DEVICE LOT #: 2245743, D4. MEDICAL DEVICE EXPIRATION DATE: 2024-01-31, H4. DEVICE MANUFACTURE DATE: 2022-09-02 . E.6: INITIAL REPORTER E-MAIL: (B)(6). H.6 INVESTIGATION SUMMARY: MATERIAL #: 368856, LOT/BATCH #: 2153625, 2245743, 2245743. BD HAD NOT RECEIVED SAMPLES, BUT TWO (2) PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR UNDERFILL WAS OBSERVED. ADDITIONALLY, TWENTY (20) RETENTION SAMPLES FROM EACH LOT 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® K3E 5.4MG PLUS BLOOD COLLECTION TUBES THAT THERE WAS A RAISED FILL VOLUME ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER RAISED FILL VOLUME ISSUE IN 368856 EDTA 3ML TUBE, ,1 ML SAMPLE IS COMING IN 3ML TUBE DURING PHLEBOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270279 BD VACUTAINER® K3E 5.4MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2227720

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown