BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK SYRINGE

    MDR report key: 8527047 · Received April 18, 2019

    Report

    Report Number
    3003152976-2019-00274
    Event Type
    Malfunction
    Date Received
    April 18, 2019
    Date of Event
    April 3, 2019
    Report Date
    May 8, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE SAMPLE AND THREE PHOTOS WERE PROVIDED TO OUR QUALITY ENGINEER FOR INVESTIGATION. THROUGH VISUAL INSPECTION, BLACK SPOTS WERE OBSERVED ON THE BARREL. FURTHER EVALUATION DETERMINED THE SPOTS TO CONSIST OF EMBEDDED POLYPROPYLENE MATERIAL FROM THE MOLDING PROCESS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1810227 , NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED ISSUES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. MACHINES ROUTINELY UNDERGO PROPER MAINTENANCE AND CLEANING AND PRODUCT IS BOTH VISUALLY AND FUNCTIONALLY TESTED TO AVOID ANY DEFECTS. THIS IS A COSMETIC DEFECT THAT WILL NOT AFFECT THE FUNCTIONALITY OF THE SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ SYRINGE HAD FOREIGN MATTER IN IT. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM SENDING YOU THIS EMAIL TO LET YOU KNOW THAT WE HAD A 50ML SYRINGE ON WHICH THERE WAS STILL A RESIDUAL OF COLOUR (IN MY OPINION). THE EXACT REFERENCE OF THE SYRINGE IS 300865. THIS IS THE BATCH: 1810227 WITH AN EXPIRY DATE OF 09/2023.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 · 1

    IT WAS REPORTED THAT BD PLASTIPAK¿ SYRINGE HAD FOREIGN MATTER IN IT. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM SENDING YOU THIS EMAIL TO LET YOU KNOW THAT WE HAD A 50ML SYRINGE ON WHICH THERE WAS STILL A RESIDUAL OF COLOUR (IN MY OPINION). THE EXACT REFERENCE OF THE SYRINGE IS 300865. THIS IS THE BATCH: 1810227 WITH AN EXPIRY DATE OF 09/2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318833 BD PLASTIPAK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1810227

    Patients

    Seq Age Sex Outcome Treatment
    1 Other