BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21401943 · Received February 18, 2025

    Report

    Report Number
    1024879-2025-00138
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    January 16, 2025
    Report Date
    August 12, 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

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED: D4. MEDICAL DEVICE LOT #: 4157674 D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2027 H4. DEVICE MANUFACTURE DATE: 05-JUN-2024. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED FOUR PHOTOS FOR INVESTIGATION. THE CUSTOMER PHOTOS SHOW DEVICES WITH DAMAGED COLLARS RESULTING IN HUB/COLLAR SEPARATION. FOR LOT 4157674, A TOTAL OF 20 RETAINED SAMPLES WERE INSPECTED FOR HUB/COLLAR SEPARATION AND DEFECTIVE LOCKING MECHANISM. THE SAMPLES PASSED FUNCTIONAL TESTS AS THERE WERE NO SIGNS OF DAMAGE OR SEPARATION DURING THE ACTIVATION OF THE SAFETY SHIELD. FOR LOT 4051452, A TOTAL OF 20 RETAINED SAMPLES WERE INSPECTED FOR THE SAME ISSUES AND ALSO PASSED FUNCTIONAL TESTS WITHOUT ANY SIGNS OF DAMAGE OR SEPARATION. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE LOTS 4051452 AND 4157674, FOR THE INDICATED FAILURE MODE: HUB/COLLAR SEPARATION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, THE CANNULA HUB SEPARATED FROM THE COLLAR ON AN UNSPECIFIED NUMBER OF UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, THE CANNULA HUB SEPARATED FROM THE COLLAR ON AN UNSPECIFIED NUMBER OF UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58852 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 4051452 50382903686501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown