BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 18703727 · Received February 14, 2024

    Report

    Report Number
    1024879-2024-00129
    Event Type
    Malfunction
    Date Received
    February 14, 2024
    Date of Event
    January 26, 2024
    Report Date
    May 22, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    30382903686095
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    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: 26-FEB-2024. INVESTIGATION SUMMARY MATERIAL #: 368609. LOT/BATCH #: 3221763 . BD RECEIVED 10 SAMPLES AND 6 PHOTOS FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODES FOR HUB-COLLAR SEPARATION AND DAMAGED HUB WERE OBSERVED. TWO OF THE RETURNED SAMPLES FAILED EVALUATION AS ONE HAD HUB-COLLAR SEPARATION AND THE OTHER HAD A DAMAGED HUB. ADDITIONALLY, 20 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING AND THE ISSUES OF HUB-COLLAR SEPARATION AND DAMAGED HUB 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 HUB-COLLAR SEPARATION AND DAMAGED HUB. 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. 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 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, THERE WAS HUB SEPARATION SEEN IN A LARGE NUMBER OF DEVICES. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, THERE WAS HUB SEPARATION SEEN IN A LARGE NUMBER OF DEVICES. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389812 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 3221763 30382903686095

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown