BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 15019148 · Received July 14, 2022

    Report

    Report Number
    1024879-2022-00370
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Date of Event
    June 14, 2022
    Report Date
    August 18, 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
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9. DEVICE AVAILABLE FOR EVALUATION? YES. D9. RETURNED TO MANUFACTURER ON: 06/21/2022. H.6. INVESTIGATION SUMMARY: MATERIAL #: 368607, LOT/BATCH #: 2090159. BD RECEIVED 4 SHELF CARTONS OF SAMPLES FOR INVESTIGATION. TEN (10) OF THE SAMPLES WERE CHOSEN AT RANDOM AND EVALUATED BY FUNCTIONAL TESTING, EACH USED TO DRAW 10 TUBES WITH WATER, AND THE INDICATED FAILURE MODE FOR SLEEVE LEAKAGE WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. 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 SLEEVE LEAKAGE. 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 WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THAT THE SAFETY SHIELD DOES NOT RETRACT THUS CAUSING BLOOD TO SPILL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "IT WAS REPORTED BY THE CUSTOMER THAT THE SAFETY SHIELD DOES NOT RETRACT THUS CAUSING BLOOD TO SPILL."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THAT THE SAFETY SHIELD DOES NOT RETRACT THUS CAUSING BLOOD TO SPILL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "IT WAS REPORTED BY THE CUSTOMER THAT THE SAFETY SHIELD DOES NOT RETRACT THUS CAUSING BLOOD TO SPILL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2062904 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