BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES

    MDR report key: 16140536 · Received January 11, 2023

    Report

    Report Number
    1917413-2023-00024
    Event Type
    Malfunction
    Date Received
    January 11, 2023
    Date of Event
    December 15, 2022
    Report Date
    January 6, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903630832
    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

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2080614, MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2022, DEVICE MANUFACTURE DATE: 21-MAR-2022, MEDICAL DEVICE LOT #: 2109028, MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2023, DEVICE MANUFACTURE DATE: 19-APR-2022. INVESTIGATION SUMMARY: BD RECEIVED (B)(4) SAMPLES FROM LOT 2109028 AND, (B)(4) SAMPLES FROM LOT 2080614 IN SUPPORT OF THIS COMPLAINT. (B)(4) SAMPLE TUBES FROM BOTH LOTS, ALONG WITH (B)(4) RETENTION SAMPLES FROM EACH LOT OF THE BD INVENTORY WERE FUNCTIONALLY TESTED AND THE ISSUE OF UNDERFILL WAS NOT OBSERVED AS ALL TUBES WERE WITHIN SPECIFICATION LIMITS. BD WAS UNABLE TO CONFIRM AND/OR DUPLICATE THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE THE DEFECT WAS NOT OBSERVED IN THE SAMPLE AND RETENTION TESTING. BD WAS UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED ISSUE. 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. 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 IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH 2 LOTS OF BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES THE TUBES WERE UNDER-FILLING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CONFIRMED THAT WHEN THEY STATE THE TUBES ARE "UNDER-FILLED" IT MEANS THE LEVEL OF BLOOD IN THE TUBE IS BELOW THE MINIMUM FILL LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119134 BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 363083 SEE H.10 50382903630832

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown