BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES

    MDR report key: 18039824 · Received October 31, 2023

    Report

    Report Number
    9617032-2023-01579
    Event Type
    Malfunction
    Date Received
    October 31, 2023
    Date of Event
    October 13, 2023
    Report Date
    October 30, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903630481
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 3163213. D4. MEDICAL DEVICE EXPIRATION DATE: 29-FEB-2024. H4. DEVICE MANUFACTURE DATE: 12-JUN-2023. D4. MEDICAL DEVICE LOT #: 3187210. D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2024. H4. DEVICE MANUFACTURE DATE: 06-JUL-2023. D4. MEDICAL DEVICE LOT #: 3180410. D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2024. H4. DEVICE MANUFACTURE DATE: 29-JUN-2023. H3. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR OVERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. THE TUBE SHOWS ACCEPTABLE FILL. ADDITIONALLY, 20 RETENTION SAMPLES FROM EACH OF THE THREE LOTS FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO OVERFILL 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 IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE OVERFILL. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES, THE TUBES OVERFILLED. THIS OCCURRED 3 TIMES. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: WE ARE ENCOUNTERING PROBLEMS WITH ¿OVER¿FILLING OF CITRATED TUBES. THE ANALYZES ARE NOT CARRIED OUT BY OUR COAGULATION MACHINES (AUTOMATON: STA RMAX / STA COMPACT MAX FROM STAGO) WHICH DETECT THE FILLING LEVELS OF THE TUBES, REQUIRING PATIENTS TO BE RE-SAMPLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2226271 BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H10 50382903630481

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown