BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES

    MDR report key: 18116083 · Received November 10, 2023

    Report

    Report Number
    1917413-2023-01142
    Event Type
    Malfunction
    Date Received
    November 10, 2023
    Date of Event
    October 13, 2023
    Report Date
    December 1, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903630801
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: MATERIAL #: 363080. LOT/BATCH #: 3111755. BD RECEIVED (B)(4) SAMPLES ON 3111755, (B)(4) SAMPLES ON LOT 3136113, AND (B)(4) PHOTOS FOR INVESTIGATION. NO INVESTIGATION WAS REQUIRED ON THE SAMPLES FOR LOT 3136113 AS THE CUSTOMER RETRACTED THE COMPLAINT FOR THIS LOT ONLY. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR UNDERFILL WAS OBSERVED AS THE TOP OF THE LIQUID IS BELOW THE ETCHED FILL LINE. NO TESTING COULD BE PERFORMED ON THE RETURNED SAMPLES FROM LOT 3111755 AS THE PRODUCT WAS EXPIRED (31OCT2023) AT THE TIME OF INVESTIGATION. THEREFORE (B)(4) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO UNDERFILL AS ALL SAMPLES MET SPECIFICATIONS. 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 UNDERFILL. 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. THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION. D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 09-NOV-2023.

    Additional Manufacturer Narrative · 0

    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

    REPORT 7 OF 10. IT WAS REPORTED THAT WHILE USING BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES THAT THERE WAS UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. CUSTOMER IS REPORTING THAT ITEM 363080. LOT# 3111755 IS UNDERFILLING.

    Description of Event or Problem · 0

    REPORT 7 OF 10. IT WAS REPORTED THAT WHILE USING BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES THAT THERE WAS UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. CUSTOMER IS REPORTING THAT ITEM 363080. LOT# 3111755 IS UNDERFILLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228249 BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 3111755 50382903630801

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown