BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES

    MDR report key: 16950262 · Received May 17, 2023

    Report

    Report Number
    9617032-2023-00566
    Event Type
    Malfunction
    Date Received
    May 17, 2023
    Date of Event
    April 22, 2023
    Report Date
    May 22, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903678568
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. E.6 INITIAL REPORTER E-MAIL: (B)(6). H.3. 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 MATERIAL #: 368856; LOT/BATCH #: 2150169. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, TWENTY (20) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING] AND NO ISSUES WERE OBSERVED RELATING TO UNDERFILL AS ALL SAMPLES MET SPECIFICATIONS. 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 IS UNABLE TO BE 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 THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES THAT TUBES ARE ONLY FILLING 3/4 OF THE WAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: CUSTOMER REPORTS THAT TUBES ARE ONLY FILLING 3/4 OF THE WAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES THAT TUBES ARE ONLY FILLING 3/4 OF THE WAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: CUSTOMER REPORTS THAT TUBES ARE ONLY FILLING 3/4 OF THE WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705613 BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 367856 2150169 50382903678568

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown