BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES

    MDR report key: 17558840 · Received August 16, 2023

    Report

    Report Number
    1917413-2023-00807
    Event Type
    Malfunction
    Date Received
    August 16, 2023
    Date of Event
    August 3, 2023
    Report Date
    August 28, 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
    RP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER PHONE #: (B)(6). H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: MATERIAL #: 363080. LOT/BATCH #: 3111755. BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR MISSING LABEL WAS OBSERVED. ADDITIONALLY A RETENTION SHELF PACK WAS VISUALLY INSPECTED AND NO ISSUES WERE FOUND. THE RETENTION SHELF PACK DOES HAVE THE CORRECT SHELF PACK LABEL ADHERED TO THE SIDE. 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 MISSING LABEL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES, 3 PACKS WERE FOUND TO HAVE NO LABEL. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UPON REDRESSING OF THE SHIPMENT RECEIVED LAST JULY 29, 2023 , AN ISSUE WAS FOUND. NO LABEL STICKER (3PACKS)."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES, 3 PACKS WERE FOUND TO HAVE NO LABEL. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UPON REDRESSING OF THE SHIPMENT RECEIVED LAST JULY 29, 2023 , AN ISSUE WAS FOUND. NO LABEL STICKER (3PACKS)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578288 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