BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET¿ ECLIPSE¿

    MDR report key: 19014336 · Received April 1, 2024

    Report

    Report Number
    9617032-2024-00476
    Event Type
    Malfunction
    Date Received
    April 1, 2024
    Date of Event
    February 25, 2024
    Report Date
    May 2, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903643900
    PMA / PMN Number
    K022426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. 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 #: 2243678 BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING, EACH DRAWN WITH WATER AND HAVING THEIR HEMOGARD CAP ATTACHED, AND NO ISSUES WERE OBSERVED RELATING TO LEAKAGE 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 LEAKAGE. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PRESET¿ ECLIPSE¿ WHEN THE GREEN CAP WAS REPLACED, THE BLOOD SPECIMEN AUTOMATICALLY FLOWED INTO THE GREEN CAP, NO SPECIMEN IN THE SYRINGE, THE NURSE IMMEDIATELY REPLACED THE NEW BLOOD COLLECTOR. BLOOD WAS RECOLLECTED FROM PATIENT AND NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PRESET¿ ECLIPSE¿ WHEN THE GREEN CAP WAS REPLACED, THE BLOOD SPECIMEN AUTOMATICALLY FLOWED INTO THE GREEN CAP, NO SPECIMEN IN THE SYRINGE, THE NURSE IMMEDIATELY REPLACED THE NEW BLOOD COLLECTOR. BLOOD WAS RECOLLECTED FROM PATIENT AND NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362306 BD PRESET¿ ECLIPSE¿ BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2243678 50382903643900

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown