BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17364002 · Received July 20, 2023

    Report

    Report Number
    1917413-2023-00671
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    July 3, 2023
    Report Date
    July 14, 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

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 2200102. D4. MEDICAL DEVICE EXPIRATION DATE: 30-11-2023. H4. DEVICE MANUFACTURE DATE: 19-07-2022. D4. MEDICAL DEVICE LOT#: 2227120. D4. MEDICAL DEVICE EXPIRATION DATE: 31-12-2023. H4. DEVICE MANUFACTURE DATE: 08-15-2022. B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.6. INVESTIGATION SUMMARY: NO CUSTOMER SAMPLES BUT 3 PHOTOS WERE RETURNED BY THE CUSTOMER IN SUPPORT OF THIS COMPLAINT FOR CATALOG 367856, LOT NUMBERS 2200102 AND 2227120. VISUAL EXAMINATION OF PHOTOS WAS PERFORMED AND REVEALED CORING IN THE TUBE STOPPER AS IT APPEARS TO BE A PIECE OF STOPPER ADHERED TO THE SIDEWALL OF THE TUBE. 10 PRODUCTION LOT IN-HOUSE RETENTION SAMPLES FROM BOTH LOTS WERE TESTED, ALL WEIGHTS WERE WITHIN SPECIFICATION LIMITS WITH NO STOPPER CORING OBSERVED. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE PHOTOS PROVIDED. THE EXACT CAUSE FOR THE CUSTOMER¿S FAILURE MODE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, A PIECE OF STOPPER ADHERED TO THE SIDEWALL OF 31 TUBES FOR LOT 2200102 AND 19 TUBES FOR LOT 2227120. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BECAUSE THE CONVENTIONAL RUBBER STOPPERS EMBRITTLEMENT, WHICH LEADS TO THE OBSTRUCTION OF PROBE OF AUTOMATED CELL COUNTERS, RESULTING THE SAMPLE CONTAMINATION AND INSTRUMENT FAILURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883841 BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367856 SEE H.10 50382903678568

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown