BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 19842929 · Received July 26, 2024

    Report

    Report Number
    1024879-2024-00665
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    June 10, 2024
    Report Date
    October 2, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    30382903686071
    PMA / PMN Number
    K982541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL LOT NUMBER REPORTED: D4. MEDICAL DEVICE LOT#: 3222294. D4. MEDICAL DEVICE EXPIRATION DATE: 31-07-2028. H4. DEVICE MANUFACTURE DATE: 10-08-2023. 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 HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 29-JUL-2024. INVESTIGATION SUMMARY: BD RECEIVED 20 SAMPLES FROM LOT NUMBER 3347044 AND 8 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODES FOR HOOKED NEEDLE POINT AND FOREIGN MATTER WERE OBSERVED. THE CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODES FOR HOOKED NEEDLE POINT AND FOREIGN MATTER WITH THE INCIDENT LOT WERE NOT OBSERVED. ADDITIONALLY, 30 RETENTION SAMPLES OF EACH REPORTED LOT NUMBER FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF HOOKED NEEDLE POINT AND FOREIGN MATTER WERE 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 MODES HOOKED NEEDLE POINT AND FOREIGN MATTER. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODES. 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 NEEDLES, FOREIGN MATTER WAS FOUND ON THE CANNULA AND THE NEEDLE POINTS WERE HOOKED / NOT SHARP. THESE DEFECTS WERE OBSERVED IN AN UNSPECIFIED NUMBER OF DEVICES. NO IMPACT WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLES, FOREIGN MATTER WAS FOUND ON THE CANNULA AND THE NEEDLE POINTS WERE HOOKED / NOT SHARP. THESE DEFECTS WERE OBSERVED IN AN UNSPECIFIED NUMBER OF DEVICES. NO IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1733161 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 3347044 30382903686071

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown