BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E (EDTA) PLUS BLOOD COLLECTION TUBES

    MDR report key: 17397630 · Received July 26, 2023

    Report

    Report Number
    9617032-2023-00965
    Event Type
    Malfunction
    Date Received
    July 26, 2023
    Date of Event
    July 7, 2023
    Report Date
    July 23, 2023
    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. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D4. MEDICAL DEVICE LOT #: 3031097. D4. MEDICAL DEVICE EXPIRATION DATE: 2024-06-30. H4. DEVICE MANUFACTURE DATE: 2023-01-31. D4. MEDICAL DEVICE LOT #: 3073165. D4. MEDICAL DEVICE EXPIRATION DATE: 2024-07-31. H4. DEVICE MANUFACTURE DATE: 2023-03-14. H.6 INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT ONE (1) PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR ADDITIVE ABNORMALITY WAS OBSERVED. ADDITIONALLY, ONE HUNDRED (100) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF ADDITIVE ABNORMALITY 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 ADDITIVE ABNORMALITY. 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

    HOLD LM 7.27IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® K2E (EDTA) PLUS BLOOD COLLECTION TUBES THAT THERE WAS DISCOLORED / ABNORMAL ADDITIVE FORM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN SEVERAL BATCHES OF EDTA TUBES, REFERENCE (B)(4), WE HAVE NOTED THE PRESENCE OF SUSPICIOUS DEPOSITS IN THE FORM OF YELLOWISH POINTS ON THE WALLS. THESE TUBES ARE MIXED RANDOMLY WITHIN THE SAME PLATE. IT APPEARS TO BE CRYSTALLIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1839632 BD VACUTAINER® K2E (EDTA) PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3065604 50382903688611

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown