BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE ECLIPSE 25X5/8

    MDR report key: 20276006 · Received September 22, 2024

    Report

    Report Number
    2243072-2024-00985
    Event Type
    Malfunction
    Date Received
    September 22, 2024
    Date of Event
    August 26, 2024
    Report Date
    October 21, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903057597
    PMA / PMN Number
    K010188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF SAFETY MECHANISM FAILURE WAS CONFIRMED UPON INSPECTION OF THE SAMPLE. ANALYSIS OF THE SAMPLE SHOWED THE SAFETY SHIELD DETACHED FROM THE NEEDLE HUB. THE SAMPLE WAS SUBJECTED TO INNER DIAMETER INSPECTION OF THE HUB HOOK AND INSPECTION FOR SAFETY SHIELD ROUNDNESS. THE OUTER DIAMETER OF THE PIVOT ROD WAS ALSO INSPECTED. ALL PARAMETERS WERE FOUND TO BE WITHIN SPECIFICATION. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS LOT MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS. THE ROOT CAUSE COULD NOT BE DETERMINED AS THE PARAMETERS WERE FOUND WITHIN SPECIFICATION. BASED ON AVAILABLE INFORMATION THIS IS AN ISOLATED CASE AND THE PROBABLE CAUSE COULD BE ATTRIBUTED TO USER ERROR DURING ACTIVATION.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    MATERIAL#: 305759, BATCH#: 4023388. IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING BD SAFETY ECLIPSE, THE PINK SHIELD DETACHED FROM THE SYRINGE WHEN NURSE WENT TO ACTIVATE THE SAFETY. THE LEFT THE NEEDLE UNSHIELDED AND AT RISK FOR A NEEDLESTICK INJURY. VERBATIM: WHEN USING BD SAFETY ECLIPSE, THE PINK SHIELD DETACHED FROM THE SYRINGE WHEN NURSE WENT TO ACTIVATE THE SAFETY. THE LEFT THE NEEDLE UNSHIELDED AND AT RISK FOR A NEEDLESTICK INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X5/8 SAFETY MECHANISM FAILED IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING BD SAFETY ECLIPSE, THE PINK SHIELD DETACHED FROM THE SYRINGE WHEN NURSE WENT TO ACTIVATE THE SAFETY. THE LEFT THE NEEDLE UNSHIELDED AND AT RISK FOR A NEEDLESTICK INJURY. VERBATIM: WHEN USING BD SAFETY ECLIPSE, THE PINK SHIELD DETACHED FROM THE SYRINGE WHEN NURSE WENT TO ACTIVATE THE SAFETY. THE LEFT THE NEEDLE UNSHIELDED AND AT RISK FOR A NEEDLESTICK INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1801444 BD NEEDLE ECLIPSE 25X5/8 HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 4023388 00382903057597

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown