BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE ECLIPSE 25X5/8

    MDR report key: 18074797 · Received November 6, 2023

    Report

    Report Number
    2243072-2023-02000
    Event Type
    Malfunction
    Date Received
    November 6, 2023
    Date of Event
    October 5, 2023
    Report Date
    December 21, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903057598
    PMA / PMN Number
    K010188
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON DEVICE HISTORY RECORD REVIEW, NO ABNORMALITY WAS OBSERVED DURING THE PRODUCTION OF THE AFFECTED BATCHES. CURRENT CONTROL THERE IS A VISUAL INSPECTION ON BROKEN CANNULA CATCH/CANNULA LOCK PIN PER MFG-043/H AT THE SAFETY SHIELD MOLDING IN-PROCESS INSPECTION; FAIL HOOK ID INSPECTION ON THE ECLIPSE HUB MOLDING IN-PROCESS INSPECTION PER MFG-043/AA; ACTIVATION/LOCKING FORCE FUNCTIONAL TEST, DEACTIVATION/UNLOCKING FORCES FUNCTIONAL TEST AND ECLIPSE SAFETY SHIELD INSPECTION AT THE QA OUTGOING INSPECTION PER MQA-052/B; AND VISUAL INSPECTION OF DAMAGE PIVOT PIN AT THE PACKAGING IN-PROCESS INSPECTION PER MFG-043/K. ACTUAL ROOT CAUSE COULD NOT BE DETERMINED AS NO SAMPLE WERE RECEIVED FOR INVESTIGATION. THE COMPLAINT WILL BE RE-OPENED AND RE-INVESTIGATED WHEN SAMPLE IS RECEIVED. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    MAT#:305759 BATCH#:1362825. IT WAS REPORTED BY THE CUSTOMER THAT "DISFUNCTION OF NEEDLE SAFETY COVERING IN WHICH IT WOULD NOT COVER THE NEEDLE AND RESULTED IN AN EXPOSURE". VERBATIM: DISFUNCTION OF NEEDLE SAFETY COVERING IN WHICH IT WOULD NOT COVER THE NEEDLE AND RESULTED IN AN EXPOSURE. 17 OCT 23. -COULD YOU PLEASE ADVISE THE DETAIL OF THE INCIDENT. NURSING STUDENT STUCK THEMSELVES THIS A DIRTY NEEDLE. THE CAP DID NOT CLOSE PROPERLY. -DO YOU HAVE PHOTO SHOWING THE INCIDENT? NO. -IS THERE ANY ADVERSE EVENT ON PATIENT/USER? USER WAS STUCK BY THE NEEDLE. -IS THERE ANY MEDICAL INTERVENTION NEEDED DUE TO THE INCIDENT? BLOOD DRAW ON THE PARTIES INVOLVED . IF YOU NEED ADDITIONAL INFO LET ME KNOW.

    Description of Event or Problem · 0

    IT WAS REPORTED BD NEEDLE ECLIPSE 25X5/8 NEEDLE PIERCED THROUGH SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; IT WAS REPORTED BY THE CUSTOMER THAT "DISFUNCTION OF NEEDLE SAFETY COVERING IN WHICH IT WOULD NOT COVER THE NEEDLE AND RESULTED IN AN EXPOSURE". VERBATIM: DISFUNCTION OF NEEDLE SAFETY COVERING IN WHICH IT WOULD NOT COVER THE NEEDLE AND RESULTED IN AN EXPOSURE. (B)(6) 2023. COULD YOU PLEASE ADVISE THE DETAIL OF THE INCIDENT. NURSING STUDENT STUCK THEMSELVES THIS A DIRTY NEEDLE. THE CAP DID NOT CLOSE PROPERLY DO YOU HAVE PHOTO SHOWING THE INCIDENT? NO IS THERE ANY ADVERSE EVENT ON PATIENT/USER? USER WAS STUCK BY THE NEEDLE IS THERE ANY MEDICAL INTERVENTION NEEDED DUE TO THE INCIDENT? BLOOD DRAW ON THE PARTIES INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1929082 BD NEEDLE ECLIPSE 25X5/8 HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 1362825 30382903057598

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other