BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CAT (CLOT ACTIVATOR TUBE) PLUS BLOOD COLLECTION TUBES

    MDR report key: 21938352 · Received April 30, 2025

    Report

    Report Number
    9617032-2025-00735
    Event Type
    Malfunction
    Date Received
    April 30, 2025
    Date of Event
    April 1, 2025
    Report Date
    May 30, 2025
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    30382903690320
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED EIGHT PHOTOS FOR INVESTIGATION. EVALUATION OF THESE PHOTOS SHOWED THAT THE EXPIRY DATE DID NOT MATCH THE LOT NUMBER, INDICATING THAT THE LABEL MIGHT HAVE BEEN TAMPERED WITH OR COUNTERFEITED. ONE PHOTO SHOWS AN 'F' IN FRONT OF THE CATALOGUE NUMBER, SUGGESTING INCORRECT COUNTERFEITING. THE PRODUCT EXPIRED ON 31 DEC 2023. THUS, NO RETAINED SAMPLES WERE AVAILABLE FOR INSPECTION. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE LOTS 2203614 AND UNKNOWN, FOR THE INDICATED FAILURE MODE: INCORRECT LABEL CONTENT. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. 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 THE IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER FACILITY NAME: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    REPORT 2 OF 2: IT WAS REPORTED WHILE USING BD VACUTAINER® CAT (CLOT ACTIVATOR TUBE) PLUS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF SHELF PACKS EXHIBITED INCORRECT LABEL INFORMATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USE.

    Description of Event or Problem · 0

    REPORT 2 OF 2 IT WAS REPORTED WHILE USING BD VACUTAINER® CAT (CLOT ACTIVATOR TUBE) PLUS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF SHELF PACKS EXHIBITED INCORRECT LABEL INFORMATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2356557 BD VACUTAINER® CAT (CLOT ACTIVATOR TUBE) PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2203614 30382903690320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown