BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB

    MDR report key: 21434309 · Received February 21, 2025

    Report

    Report Number
    2243072-2025-00124
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Date of Event
    February 5, 2025
    Report Date
    March 27, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903057870
    PMA / PMN Number
    K010188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE PHOTOS, AND SAMPLE SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF FOREIGN MATTER WAS CONFIRMED UPON INSPECTION OF THE SAMPLE. ANALYSIS OF THE SAMPLE SHOWED A STICKY SUBSTANCE ON THE SAMPLE. THE SUBSTANCE WAS DETERMINED TO BE EXCESSIVE AMOUNTS OF SILICONE. THE SAMPLE WAS SUBJECTED TO A SILICONE CONTENT TEST AND THE SAMPLE FAILED THE FUNCTIONAL TEST. 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 BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS. THE ROOT CAUSE FOR THE FOREIGN MATERIAL IS DUE TO INTERMITTENT POOR RELAY FEEDBACK FROM THE SLIP RING TO THE SILICONE GUN DURING PRODUCTION. ACTION HAD BEEN TAKEN TO REPLACE THE OLD SLIP RING TO ADDRESS THE ISSUE OF POOR SIGNAL RELAY TO THE SILICONE GUN. THE REPLACEMENT WAS DONE ON (B)(6) 2024. THE SYRINGE BATCH IS PRODUCED IN FEB 2024 WHICH IS BEFORE THE ACTION IMPLEMENTATION.

    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

    NO ADDITIONAL INFORMATION

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB HAD FOREIGN MATTER. IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD A STICKY SUBSTANCE IN THE SYRINGE. RCC RECEIVED A COMPLAINT VIA PHONE. PRODUCT COMPLAINT: CUSTOMER CALLED TO REPORT, WHILE USING TRYING TO DRAW UP AIR SHE NOTICED THE BD SYRINGE REF: 305787, LOT: 4043533, HAD A STICKY SUBSTANCE IN THE SYRINGE. NOT USED ON A PT, NO PT HARM, SAMPLE AVAILABLE, DOE ON 02/05.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472744 BD SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 4043533 00382903057870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown