BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES

    MDR report key: 16328060 · Received February 8, 2023

    Report

    Report Number
    9617032-2023-00152
    Event Type
    Malfunction
    Date Received
    February 8, 2023
    Date of Event
    January 10, 2023
    Report Date
    July 15, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903630955
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MAT: 363095. LOT: 2122528. BD DID NOT RECEIVE SAMPLES OR PHOTOGRAPHS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THE EXPIRY DATE OF THE LOT NUMBER INVOLVED WAS JANUARY 2022. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE THE TUBES HAS EXPIRED, HOWEVER RETAINED TUBES FOR A PREVIOUS INVESTIGATION HAVE BEEN EVALUATED FOR THE SAME DEFECT: UNDERFILL, AND RESULTS WERE SATISFACTORY. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. 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 WHEN USING THE BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN THE NURSE USED THE VACUUM BLOOD COLLECTION TUBE TO COLLECT BLOOD FROM THE PATIENT, THE NEGATIVE PRESSURE IN THE VACUUM BLOOD COLLECTION TUBE WAS INSUFFICIENT, AND THE DRAWN BLOOD DID NOT REACH THE SPECIFIED SCALE LINE, AND THE PATIENT DID NOT SUFFER ANY INJURIES."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN THE NURSE USED THE VACUUM BLOOD COLLECTION TUBE TO COLLECT BLOOD FROM THE PATIENT, THE NEGATIVE PRESSURE IN THE VACUUM BLOOD COLLECTION TUBE WAS INSUFFICIENT, AND THE DRAWN BLOOD DID NOT REACH THE SPECIFIED SCALE LINE, AND THE PATIENT DID NOT SUFFER ANY INJURIES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2313382 BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 363095 2122528 50382903630955

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown