BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PRESET¿ ECLIPSE¿

    MDR report key: 19343554 · Received May 17, 2024

    Report

    Report Number
    9617032-2024-00775
    Event Type
    Injury
    Date Received
    May 17, 2024
    Date of Event
    April 18, 2024
    Report Date
    May 22, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903643900
    PMA / PMN Number
    K202446
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE #: (B)(6). 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

    H.6 INVESTIGATION SUMMARY MATERIAL #: 364390. LOT/BATCH #: 3081043. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO DEFECTIVE LOCKING MECHANISM AS ALL SAMPLES MET SPECIFICATIONS. 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 IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE DEFECTIVE LOCKING MECHANISM. 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 THAT WHILE USING THE BD PRESET¿ ECLIPSE¿ A NURSE PRICKED HER LEFT HAND DUE TO THE SAFETY SHIELD FAILING TO COVER THE IV NEEDLE. REPORT 2 OF 2.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD PRESET¿ ECLIPSE¿ A NURSE PRICKED HER LEFT HAND DUE TO THE SAFETY SHIELD FAILING TO COVER THE IV NEEDLE. REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2490533 BD PRESET¿ ECLIPSE¿ BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3081043 50382903643900

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other