BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3 ML LL BNS

    MDR report key: 16747364 · Received April 14, 2023

    Report

    Report Number
    1213809-2023-00371
    Event Type
    Malfunction
    Date Received
    April 14, 2023
    Date of Event
    March 27, 2023
    Report Date
    April 28, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903010738
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON EXAMINATION OF THE RETURNED PHOTOS, IT WAS OBSERVED THAT SILICONE VISIBLE ON THE TIP OF THE STOPPER. FROM THE PHOTOS PROVIDED THE AMOUNT OF SILICONE IS ACCEPTABLE PER PRODUCT SPECIFICATION. PLEASE NOTE THAT SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2201648. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. 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

    IT WAS REPORTED WHILE USING BD SYRINGE 3 ML LL BNS FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE A RECENT COMPLAINT FROM A CUSTOMER THAT IS SEEING SIGNIFICANT MOISTURE INSIDE ALL OF SYRINGES IN THEIR PACKS. I AM HOPING YOU CAN PROVIDE A DOCUMENT THAT ADDRESSES MOISTURE INSIDE OF THE SYRINGES FROM A SILICONE LUBRICANT THAT IS USED IN YOUR MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SYRINGE 3 ML LL BNS FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE A RECENT COMPLAINT FROM A CUSTOMER THAT IS SEEING SIGNIFICANT MOISTURE INSIDE ALL OF SYRINGES IN THEIR PACKS. I AM HOPING YOU CAN PROVIDE A DOCUMENT THAT ADDRESSES MOISTURE INSIDE OF THE SYRINGES FROM A SILICONE LUBRICANT THAT IS USED IN YOUR MANUFACTURING PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1740272 BD SYRINGE 3 ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2201648 00382903010738

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown