BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL BRAZIL

    MDR report key: 19018544 · Received April 2, 2024

    Report

    Report Number
    1911916-2024-00233
    Event Type
    Malfunction
    Date Received
    April 2, 2024
    Date of Event
    March 21, 2024
    Report Date
    June 20, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903035526
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THERE WAS A BROKEN PLUNGER, HOLES IN PLASTIC PACKAGING, AND BLACK DIRT. TO AID IN THE INVESTIGATION, FOUR SAMPLES AND THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THREE SAMPLES CAME IN SEALED PACKAGING BLISTERS AND ONE SAMPLE CAME IN AN OPENED PACKAGING BLISTER. A VISUAL INSPECTION WAS PERFORMED. ONE SAMPLE HAS A BLACK SPECK OF EMBEDDED DEGRADED RESIN IN THE BARREL FLANGE AND ONE SAMPLE HAS DAMAGE TO THE PLUNGER ROD THUMB PRESS. THE OTHER TWO SAMPLES HAVE NO DEFECTS OBSERVED BUT DO HAVE A WRINKLE IN THE PACKAGING. 30X MAGNIFICATION WAS USED TO VERIFY THE WRINKLE IS NOT A HOLE. THE PHOTOS PROVIDED SHOW FOUR PACKAGING BLISTERS, A SYRINGE BARREL WITH FOREIGN MATTER AND A DAMAGED PLUNGER ROD THUMB PRESS. FROM THE PHOTO, IT IS NOT POSSIBLE TO DETERMINE IF THE FOREIGN MATTER IS ADHERED OR EMBEDDED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE EMBEDDED DEGRADED RESIN IN THE COMPONENT TYPICALLY OCCURS AT THE STARTUP OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. THE BROKEN PLUNGER ROD COULD OCCUR IF THERE WAS A JAM DURING THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303552, LOT 2210359. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE ASSEMBLY PROCESS WAS PERFORMED. THE RAILS AND CONVEYORS WERE ALIGNED, AND THE FLOW OF PRODUCT WAS GOOD. BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOMS OF FOREIGN MATTER AND PLUNGER ROD BROKEN REPORTED ARE CONFIRMED.

    Description of Event or Problem · 0

    2 HOLES IN PLASTIC PACKAGING.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. 2 HOLES IN PLASTIC PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052512 SYRINGE 50ML LL BRAZIL SYRINGE, PISTON FMF BECTON DICKINSON 2210359 00382903035526

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown