BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17164226 · Received June 20, 2023

    Report

    Report Number
    2243072-2023-01059
    Event Type
    Malfunction
    Date Received
    June 20, 2023
    Date of Event
    April 23, 2023
    Report Date
    June 27, 2023
    Manufacturer
    BECTON DICKINSON
    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

    LOT # 2150169 WAS PROVIDED HOWEVER ACCORDING TO SAP BATCH 2150169 DOES NOT EXIST FOR MATERIAL 367856. THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, 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, RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO UNDERFILL AS ALL SAMPLES MET SPECIFICATIONS. 20 RETAINED SAMPLES WERE DRAW-TESTED WITH DEIONIZED WATER. FROM THIS TESTING, IT WAS DETERMINED THAT ALL 20 TUBES DREW WITHIN SPECIFICATION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES ARE UNDERFILLING. VERBATIM: TUBES ARE UNDERFILLING. TUBES ARE ONLY FILLING 3/4 OF THE WAY.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES ARE UNDERFILLING. VERBATIM: TUBES ARE UNDERFILLING. TUBES ARE ONLY FILLING 3/4 OF THE WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013394 BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON 367856 2150169 50382903678568

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown