BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 20305815 · Received September 25, 2024

    Report

    Report Number
    1024879-2024-00856
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    August 23, 2024
    Report Date
    October 25, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    30382903686071
    PMA / PMN Number
    K982541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 28-AUG-2024. INVESTIGATION SUMMARY. MATERIAL #: 368607. LOT/BATCH #: 4024298. BD RECEIVED 11 SAMPLE FOR INVESTIGATION. TWO (2) OF THE SAMPLES ALREADY HAD THEIR ECLIPSE SHIELD DETACHED SO THE INDICATED FAILURE MODE OF DEFECTIVE LOCKING MECHANISM WAS OBSERVED. THE OTHER 9 SAMPLES WERE EVALUATED BY FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE FOR DEFECTIVE LOCKING MECHANISM WITH THE INCIDENT LOT WAS NOT OBSERVED. HOWEVER, ONE SAMPLE HAD A CRACKED NON-PATIENT SHIELD. 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 DEFECTIVE LOCKING MECHANISM AND CRACKED NON-PATIENT 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. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, THE USER TRIED TO ENGAGE THE SAFETY SHIELD WITH A HARD SURFACE RESULTING IN THE SAFETY SHIELD DETACHING FROM THE DEVICE. THERE WAS NO 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 USER TRIED TO ENGAGE THE SAFETY SHIELD WITH A HARD SURFACE RESULTING IN THE SAFETY SHIELD DETACHING FROM THE DEVICE. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165927 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 4024298 30382903686071

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown