BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET¿ ECLIPSE¿

    MDR report key: 20125401 · Received September 3, 2024

    Report

    Report Number
    9617032-2024-01369
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    July 26, 2024
    Report Date
    August 8, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903643917
    PMA / PMN Number
    K202446
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER PHONE #: +(B)(6). INVESTIGATION SUMMARY: MATERIAL #: 364391 LOT/BATCH #: 4003428 BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR MISSING CASE LABEL WAS OBSERVED. ADDITIONALLY, A RETENTION CASE FROM BD INVENTORY WAS EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF MISSING CASE LABEL 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 MISSING CASE LABEL. 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."

    Description of Event or Problem · 0

    IT WAS REPORTED A CASE OF BD PRESET¿ ECLIPSE¿ SYRINGES WAS MISSING ITS LABEL. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711932 BD PRESET¿ ECLIPSE¿ BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 4003428 50382903643917

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown