BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER

    MDR report key: 20879234 · Received December 9, 2024

    Report

    Report Number
    1024879-2024-01205
    Event Type
    Malfunction
    Date Received
    December 9, 2024
    Date of Event
    November 12, 2024
    Report Date
    April 24, 2025
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686501
    PMA / PMN Number
    K982541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED ONE PHOTO FOR INVESTIGATION RELATED TO LOT 4176074, SHOWING A DEVICE WITH BLOOD LEAKAGE IN THE HOLDER. ADDITIONALLY, 10 RETAINED SAMPLES FROM THE SAME LOT UNDERWENT FUNCTIONAL TESTS, AND ALL SAMPLES PASSED AS THERE WAS NO EVIDENCE OF SIDE PIERCED SLEEVES, POOR SLEEVE RECOVERY, OR SLEEVE LEAKAGE DURING THE DRAW. SIMILARLY, FOR LOT 4211150, 10 RETAINED SAMPLES FROM THIS LOT ALSO UNDERWENT FUNCTIONAL TESTS, WITH ALL SAMPLES PASSING WITHOUT EVIDENCE OF SIDE PIERCED SLEEVES, POOR SLEEVE RECOVERY, OR SLEEVE LEAKAGE DURING THE DRAW. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE LOTS 4176074 AND 4211150, FOR THE INDICATED FAILURE MODE: SLEEVE FUNCTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL LOT NUMBER REPORTED: D4. MEDICAL DEVICE LOT#: 4211150. D4. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2027. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H4. DEVICE MANUFACTURE DATE: 29-JUL-2024. 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 WITH PRE-ATTACHED HOLDER BLOOD LEAKED FROM THE NON-PATIENT END OF THE DEVICE. THIS OCCURRED WITH FIVE (5) DEVICES. 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 WITH PRE-ATTACHED HOLDER BLOOD LEAKED FROM THE NON-PATIENT END OF THE DEVICE. THIS OCCURRED WITH FIVE (5) DEVICES. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304510 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 4176074 50382903686501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown