BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 15019024 · Received July 14, 2022

    Report

    Report Number
    1024879-2022-00364
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Date of Event
    July 12, 2022
    Report Date
    July 27, 2022
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686075
    PMA / PMN Number
    K982541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, 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 EVALUTION: YES. D9: RETURNED TO MANUFACTURER ON: 2022-07-27 H.6. INVESTIGATION SUMMARY: BD RECEIVED 48 SAMPLES AND 2 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR DEFECTIVE LOCKING MECHANISM WAS OBSERVED. ADDITIONALLY, 20 OF THE CUSTOMER SAMPLES WERE EVALUATED BY FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE FOR DEFECTIVE LOCKING MECHANISM WITH THE INCIDENT LOT WAS NOT 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. 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 SHIELD WAS SLIDING OFF OR BREAKING OFF DEVICE. THIS OCCURRED TWICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS SAFETY SHIELD SLIDING OFF OR BREAKING OFF DEVICE FOR PRODUCT 368607 LOT 2090159.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THE SAFETY SHIELD WAS SLIDING OFF OR BREAKING OFF DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS SAFETY SHIELD SLIDING OFF OR BREAKING OFF DEVICE FOR PRODUCT 368607 LOT 2090159.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452018 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 368607 2090159 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown