BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES

    MDR report key: 17632272 · Received August 28, 2023

    Report

    Report Number
    9617032-2023-01159
    Event Type
    Malfunction
    Date Received
    August 28, 2023
    Date of Event
    August 9, 2023
    Report Date
    August 23, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903630955
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT ONE VIDEO WAS PROVIDED FOR INVESTIGATION. THE VIDEO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER WAS OBSERVED. ADDITIONALLY, 100 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF FOREIGN MATTER WAS NOT OBSERVED. 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 FOREIGN MATTER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES CUSTOMER FOUND AN ABNORMAL ADDITIVE IN THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE FEEDBACK WAS THAT A BLUE-HEADED TUBE (ARTICLE NUMBER 363095, BATCH NUMBER 3030792) WAS FOUND TO BE ABNORMAL IN THE ADDITIVE DOSE DURING THE PREPARATION BEFORE BLOOD COLLECTION ON AUGUST 9TH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435099 BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3030792 50382903630955

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown