BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 17800442 · Received September 22, 2023

    Report

    Report Number
    1024879-2023-00637
    Event Type
    Malfunction
    Date Received
    September 22, 2023
    Date of Event
    August 29, 2023
    Report Date
    November 17, 2023
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686075
    PMA / PMN Number
    K982541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 20 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING, EACH HAVING THEIR ECLIPSE SHIELD ACTIVATED, 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

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THE SAFETY SHIELD BROKE OFF OF NEEDLE. THERE WAS NO REPORT OF PATIENT OR USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORT A NEW INCIDENT WHERE THE SAFETY SHIELD FELL OFF DURING BLOOD COLLECTION, FROM NEEDLES 368607, LOT#: 3093593.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THE SAFETY SHIELD BROKE OFF OF NEEDLE. THERE WAS NO REPORT OF PATIENT OR USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORT A NEW INCIDENT WHERE THE SAFETY SHIELD FELL OFF DURING BLOOD COLLECTION, FROM NEEDLES 368607, LOT#: 3093593.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421945 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 3093593 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown