BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET¿ ECLIPSE¿

    MDR report key: 19274063 · Received May 8, 2024

    Report

    Report Number
    9617032-2024-00719
    Event Type
    Malfunction
    Date Received
    May 8, 2024
    Date of Event
    April 11, 2024
    Report Date
    May 17, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903643900
    PMA / PMN Number
    K202446
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES D.9:DEVICE EVAL BY MANUFACTURER? YES D9: RETURNED TO MANUFACTURER ON: 2024-MAY ¿15TH. H.6 INVESTIGATION SUMMARY: MATERIAL #: 364390. LOT/BATCH #: 3340241 AND 4003422. BD RECEIVED 6 SAMPLES, 3 FROM EACH REPORTED LOT NUMBER, FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL DRAW TESTING AND THE INDICATED FAILURE MODE FOR LEAKAGE WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES OF EACH REPORTED LOT NUMBER FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL DRAW TESTING 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. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE LOT #: 3340241. D4. MEDICAL DEVICE EXPIRATION DATE: 2025-11-30. H4. DEVICE MANUFACTURE DATE: 2023-12-06. D4. MEDICAL DEVICE LOT #: 4003422. D4. MEDICAL DEVICE EXPIRATION DATE: 2025-12-31. H4. DEVICE MANUFACTURE DATE: 2024-01-03. H.3. 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

    IT WAS REPORTED THAT WHILE USING THE BD PRESET¿ ECLIPSE¿ THAT BLOOD COMES OUT THROUGH THE PLUNGER DURING CONVENTIONAL USE OF THE PRODUCT. NO PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD PRESET¿ ECLIPSE¿ THAT BLOOD COMES OUT THROUGH THE PLUNGER DURING CONVENTIONAL USE OF THE PRODUCT. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140637 BD PRESET¿ ECLIPSE¿ BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 50382903643900

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown