BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ECLIPSE¿ NEEDLE

    MDR report key: 9520791 · Received December 26, 2019

    Report

    Report Number
    3002682307-2019-00687
    Event Type
    Injury
    Date Received
    December 26, 2019
    Date of Event
    November 22, 2019
    Report Date
    January 28, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903057603
    PMA / PMN Number
    K100209
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 305760 LOT 1903003 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1903003. AFTER REVIEWING OUR PRODUCTION AND INSPECTION RECORDS, IT IS NOT POSSIBLE TO PERFORM AN ACCURATE INVESTIGATION OF THE REPORTED ISSUE AND DETERMINE THAT THE REPORTED FAILURE MODE IS RELATED WITH NEEDLE MANUFACTURING PROCESS. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE RE-OPENED AND RE-INVESTIGATED. SINCE DEFECT IS NOT CONFIRMED AND THIS IS THE FIRST COMPLAINT RECEIVED FOR THIS DEFECT, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USE OF THE BD ECLIPSE¿ NEEDLE AS THE HCP WAS ACTIVATING THE SAFETY DEVICE THE NEEDLE SNAPPED OFF AT PORT/HUB OF CONNECTOR CAUSING NEEDLE STICK INJURY. WOUND WAS WASHED AND A BLOOD TEST APPOINTMENT WAS MADE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STAFF MEMBER CLOSED THE NEEDLE/SAFER SHARP DEVICE USING CORRECT TECHNIQUE. NO UNDUE PRESSURE OR UNDUE FORCE. NEEDLE SNAPPED OFF AT PORT/HUB OF CONNECTOR CAUSING NEEDLE STICK INJURY.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER USE OF THE BD ECLIPSE¿ NEEDLE AS THE HCP WAS ACTIVATING THE SAFETY DEVICE THE NEEDLE SNAPPED OFF AT PORT/HUB OF CONNECTOR CAUSING NEEDLE STICK INJURY. WOUND WAS WASHED AND A BLOOD TEST APPOINTMENT WAS MADE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STAFF MEMBER CLOSED THE NEEDLE/SAFER SHARP DEVICE USING CORRECT TECHNIQUE. NO UNDUE PRESSURE OR UNDUE FORCE. NEEDLE SNAPPED OFF AT PORT/HUB OF CONNECTOR CAUSING NEEDLE STICK INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313012 BD ECLIPSE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 1903003 00382903057603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention