BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 15343876 · Received September 2, 2022

    Report

    Report Number
    1024879-2022-00488
    Event Type
    Malfunction
    Date Received
    September 2, 2022
    Date of Event
    August 9, 2022
    Report Date
    October 11, 2022
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686501
    PMA / PMN Number
    K982541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    H.6. INVESTIGATION SUMMARY: "MATERIAL #: 368609 LOT/BATCH #: 2082251 BD HAD NOT RECEIVED SAMPLES, BUT 4 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR DEFECTIVE LOCKING MECHANISM WAS OBSERVED. 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 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."

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THE SAFETY DEVICE DID NOT COVER THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WANT TO MAKE YOU AWARE OF AN INCIDENT THAT HAS JUST HAPPENED IN OUR OPD. A PHLEBOTOMIST ATTEMPTED TO CLOSE THE SAFETY DEVICE AFTER TAKING BLOOD AND THE NEEDLE GOT CAUGHT ON THE PLASTIC SHEATH PREVENTING IT FROM BEING MADE SAFE, THE NEEDLE WAS DISPOSED OF UNSHEATHED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THE SAFETY DEVICE DID NOT COVER THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WANT TO MAKE YOU AWARE OF AN INCIDENT THAT HAS JUST HAPPENED IN OUR OPD. A PHLEBOTOMIST ATTEMPTED TO CLOSE THE SAFETY DEVICE AFTER TAKING BLOOD AND THE NEEDLE GOT CAUGHT ON THE PLASTIC SHEATH PREVENTING IT FROM BEING MADE SAFE, THE NEEDLE WAS DISPOSED OF UNSHEATHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677672 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 368650 2082251 50382903686501

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown