BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE PLASTIPAK 10ML S/SU

    MDR report key: 20422678 · Received October 10, 2024

    Report

    Report Number
    3003916417-2024-00239
    Event Type
    Malfunction
    Date Received
    October 10, 2024
    Date of Event
    September 4, 2024
    Report Date
    September 19, 2024
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    UDI-DI
    07891463000378
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: PHOTO RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, FOREIGN MATTER IDENTIFIED AS GREASE IS OBSERVED ON THE PLUNGER OF THE SYRINGE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 4170635, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THIS DEFECT CAN OCCUR DUE TO BURNT MATERIAL GENERATING DURING THE MOLDING PROCESS AND BECOMING INJECTED INTO THE SYRINGE MOLD, EMBEDDING THE BURNT MATERIAL. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. MACHINES UNDERGO ROUTINE CLEANING AND MAINTENANCE, AND INJECTION MACHINES ARE RAN PRIOR TO USE TO REMOVE ANY EXCESS MATERIALS, REJECTING THE FIRST FEW PIECES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE PLASTIPAK 10ML S/SU HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM PORTUGUESE TO ENGLISH: VISIBLE DIRT IN 10ML SYRINGE, LOT 4170635 FAV 2024/07. ADDITIONAL INFORMATION PROVIDED: ADDITIONAL INFORMATION FROM THE CUSTOMER SEP 23, 2024. CUSTOMER PROVIDED IMAGE AND REPORT. CUSTOMER REPORT DESCRIPTION: SYRINGE HAS DIRT IN PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346496 BD SYRINGE PLASTIPAK 10ML S/SU PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 4170635 07891463000378

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown