BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 20231749 · Received September 16, 2024

    Report

    Report Number
    1024879-2024-00815
    Event Type
    Injury
    Date Received
    September 16, 2024
    Date of Event
    August 14, 2024
    Report Date
    October 2, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    30382903686071
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY MATERIAL #: 368607. LOT/BATCH #: 4150040. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 20 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING, EACH HAVING THEIR SAFETY SHIELD ENGAGED, 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, THE SAFETY SHIELD DETACHED WHEN ATTEMPTING TO CLOSE IT OVER THE IV CANNULA. THIS RESULTED IN A USED NEEDLE STICK INJURY TO THE EMPLOYEE. THE EMPLOYEE WAS SENT TO BE SEEN BY A MEDICAL PROFESSIONAL THE SAME DAY. THERE WAS NO FURTHER REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, THE SAFETY SHIELD DETACHED WHEN ATTEMPTING TO CLOSE IT OVER THE IV CANNULA. THIS RESULTED IN A USED NEEDLE STICK INJURY TO THE EMPLOYEE. THE EMPLOYEE WAS SENT TO BE SEEN BY A MEDICAL PROFESSIONAL THE SAME DAY. THERE WAS NO FURTHER REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1900341 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 4150040 30382903686071

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other