BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 18029779 · Received October 30, 2023

    Report

    Report Number
    2243072-2023-01969
    Event Type
    Injury
    Date Received
    October 30, 2023
    Date of Event
    October 19, 2023
    Report Date
    January 24, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    50382903686075
    PMA / PMN Number
    K982541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE EXPIRATION DATE:UNKNOWN. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. H4. DEVICE MANUFACTURE DATE:UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2028. DEVICE MANUFACTURE DATE: 10-AUG-2023. MEDICAL DEVICE LOT#:3222298. IMDRF ANNEX A GRID (1): A0509 - PHYSICAL RESISTANCE / STICKING (2578/1597) DESCRIBE EVENT IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, THE SAFETY SHIELD BROKE OFF CAUSING A DIRTY NEEDLE STICK TO THE HEALTH CARE WORKER. THE FACILITY'S ESTABLISHED BLOOD EXPOSURE PROTOCOL WAS FOLLOWED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: MATERIAL #: 368607. LOT/BATCH #: 3222298. BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR DEFECTIVE LOCKING MECHANISM WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, (B)(4) 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE SAFETY SHIELD FAILED TO ACTIVATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING SAFETY SHIELD FAILED TO ACTIVATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, THE SAFETY SHIELD FAILED TO ACTIVATE CAUSING DIRTY NEEDLE STICK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING SAFETY SHIELD FAILED TO ACTIVATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, THE SAFETY SHIELD FAILED TO ACTIVATE CAUSING DIRTY NEEDLE STICK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING SAFETY SHIELD FAILED TO ACTIVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1888998 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown