BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES

    MDR report key: 18705380 · Received February 14, 2024

    Report

    Report Number
    9617032-2024-00188
    Event Type
    Malfunction
    Date Received
    February 14, 2024
    Date of Event
    January 24, 2024
    Report Date
    January 27, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    GIM
    UDI-DI
    50382903666435
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 #: 3170109. D4. MEDICAL DEVICE EXPIRATION DATE: 2024-JUN-30. H4. DEVICE MANUFACTURE DATE: 2023-JUN-19. H.6. INVESTIGATION SUMMARY: BD JAPAN RECEIVED 10 SAMPLES (LOT 3254840 AND LOT 3176109), AND 4 PHOTOGRAPHS WERE ATTACHED. EVALUATION OF BOTH INDICATES PARTIALLY FADING PRINT AND 1 CRACKED HEMOGUARD SHIELD (LOT 3163221). EMBEDDED FM WAS NOT OBSERVED. EVALUATION OF THE 100 RETAINED SAMPLES FROM EACH LOT NUMBER IDENTIFIED NO FURTHER EXAMPLES OF THIS DEFECT. 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. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODES ¿ PRINTING DEFECT, CRACKED SHIELD WITH THE PHOTOGRAPHS AND SAMPLES PROVIDED. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE ¿ EMBEDDED FM BASED ON THE EVALUATION OF THE EVIDENCE PROVIDED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES THAT THERE WAS FOREIGN MATTER IN THE TUBE AND A CRACKED LID. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442744 BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE GIM BECTON, DICKINSON AND COMPANY (BD) 3163221 50382903666435

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown