BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET¿ ECLIPSE¿

    MDR report key: 19311073 · Received May 14, 2024

    Report

    Report Number
    9617032-2024-00745
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    April 15, 2024
    Report Date
    April 25, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903643894
    PMA / PMN Number
    K202446
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1:INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. H.6 INVESTIGATION SUMMARY MATERIAL #: 364389 LOT/BATCH #: 3151632 BD RECEIVED 2 SAMPLES AND 2 PHOTOS FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODES FOR DAMAGED PLUNGER ROD AND MISSING IV SHIELD WERE OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUES OF DAMAGED PLUNGER ROD AND MISSING IV SHIELD WERE 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 MODES DAMAGED PLUNGER ROD AND MISSING IV SHIELD. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODES. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD PRESET¿ ECLIPSE¿ THAT THERE WAS NO NEEDLE CAP ON ONE DEVICE AND NO TUBE PROTECTIVE COVER ON ONE DEVICE. NO IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648314 BD PRESET¿ ECLIPSE¿ BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3151632 50382903643894

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown