BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17168222 · Received June 21, 2023

    Report

    Report Number
    1917413-2023-00572
    Event Type
    Malfunction
    Date Received
    June 21, 2023
    Date of Event
    May 30, 2023
    Report Date
    July 11, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678568
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE LOT #: 2166038. D4. MEDICAL DEVICE EXPIRATION DATE: 2023-10-31. H4. DEVICE MANUFACTURE DATE: 2022-06-15. D4. MEDICAL DEVICE LOT #: 2200096. D4. MEDICAL DEVICE EXPIRATION DATE: 2023-11-30. H4. DEVICE MANUFACTURE DATE: 2022-07-19. D4. MEDICAL DEVICE LOT #: 2200102. D4. MEDICAL DEVICE EXPIRATION DATE: 2023-11-30. H4. DEVICE MANUFACTURE DATE: 2022-07-19. 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: NO SAMPLES WERE RECEIVED, BUT (3) PHOTOS WERE RETURNED BY THE CUSTOMER IN SUPPORT OF THIS COMPLAINT FROM CATALOG 367856, LOT NUMBERS 2166038, 2200096, 2200102, AND 2227114. VISUAL EXAMINATION OF 3 OF THE PHOTOS WAS PERFORMED AND REVEALED FM AS BLACK PARTICLES CAN BE SEEN. NO SAMPLES WERE RECEIVED AT THE MANUFACTURING SITE; THEREFORE, IT IS DIFFICULT TO DETERMINE THE FM BASED ON THE PHOTOS. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE INVESTIGATION COMPLETED. THE EXACT CAUSE FOR THE CUSTOMER¿S FAILURE MODE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. 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 THERE WAS FOREIGN MATTER IN THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE INSTRUMENT FAILURE DUE TO FOREIGN MATERIAL ENTRY INTO THE WORKING ZONE. TOTAL Q'TY 20 BOXES. (100PC/BOX) 2166038*3BOX 2200096*2BOX 2200102*11BOX 2227114*4BOX.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES THAT THERE WAS FOREIGN MATTER IN THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE INSTRUMENT FAILURE DUE TO FOREIGN MATERIAL ENTRY INTO THE WORKING ZONE. TOTAL Q'TY 20 BOXES. (100PC/BOX) 2166038*3BOX¿2200096*2BOX¿2200102*11BOX¿2227114*4BOX

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1988039 BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367856 2227114 50382903678568

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown