BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E (EDTA) PLUS BLOOD COLLECTION TUBES

    MDR report key: 17370639 · Received July 21, 2023

    Report

    Report Number
    9617032-2023-00917
    Event Type
    Malfunction
    Date Received
    July 21, 2023
    Date of Event
    July 3, 2023
    Report Date
    December 28, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 28-SEP-2023. H.6. INVESTIGATION SUMMARY: BD RECEIVED 400 SAMPLES (LOT 3052281) FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. 10 RETURNED SAMPLES FROM LOT NUMBER (LOT 3052281) AND 10 RETAINED SAMPLES FROM LOT NUMBER (LOT 3024313 ), WERE DRAWN WITH WATER, CAP/STOPPER ASSEMBLIES WERE REMOVED AND REATTACHED, AND SAMPLES WERE LEFT TO STAND FOR 4 HOURS. NONE OF THE CAP/STOPPER ASSEMBLIES POPPED OFF. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE RETURNED AND RETAINED SAMPLES TEST RESULTS. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS FOR THE LOT 3052281; 3024313. ALL PROCESSES AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE LOT #: 3024313. D4. MEDICAL DEVICE EXPIRATION DATE:2024-05-31 . H4. DEVICE MANUFACTURE DATE: 2023-01-24. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® K2E (EDTA) PLUS BLOOD COLLECTION TUBES THAT THE STOPPER CREEPED OUT OR THERE WAS A LOOSE CLOSURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CAPS DON'T STAY ON THE TUBES WHEN THEY GO THROUGH THE AUTOMAT/ THROUGH THE BIOLOGIST'S HANDS. THIS OCCURRED 400 TIMES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® K2E (EDTA) PLUS BLOOD COLLECTION TUBES THAT THE STOPPER CREEPED OUT OR THERE WAS A LOOSE CLOSURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CAPS DON'T STAY ON THE TUBES WHEN THEY GO THROUGH THE AUTOMAT/ THROUGH THE BIOLOGIST'S HANDS. THIS OCCURRED 400 TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2255890 BD VACUTAINER® K2E (EDTA) PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 368861 3052281 50382903688611

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown