BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL PRECISE

    MDR report key: 12648220 · Received October 18, 2021

    Report

    Report Number
    8041187-2021-00907
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Date of Event
    September 16, 2021
    Report Date
    November 2, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: ONE SAMPLE WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE SAMPLE, BROWN EMBEDDED FOREIGN MATTER WAS OBSERVED ON THE INNER WALL OF THE SYRINGE AT TWO LOCATIONS. THE BROWN FOREIGN MATTER WAS SENT FOR MICROSCOPE FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) TESTING TO DETERMINE THE FOREIGN MATTER TYPE. THE FTIR RESULTS SHOW THAT THE SPECTRUM OF FOREIGN MATTER HAD NO GOOD MATCH AVAILABLE IN THE LIBRARY. THE FOREIGN MATTER SHOWED SOME PEAKS THAT WERE SIMILAR TO THAT OF POLYPROPYLENE, LIKELY THE BASE MATERIAL OF THE SYRINGE. THIS WAS LIKELY BECAUSE SOME OF THE BASE MATERIAL WAS EMBEDDED IN THE FOREIGN MATTER. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. THE PROBABLE CAUSE OF THIS EMBEDDED FOREIGN MATTER COULD BE A RESULT OF DEGRADED POLYPROPYLENE IN AN AGING HYDRAULIC PRESS, CLEANING OF THE INJECTION SCREW OF THE MOLDING MACHINE. THE HYDRAULIC PRESS HAS BEEN REPLACED BY AN ELECTRICAL PRESS AFTER THIS BATCH WAS PRODUCED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 50ML LL PRECISE HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROWN STAIN IN SYRINGE.

    Additional Manufacturer Narrative · 1

    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 SYRINGE 50ML LL PRECISE HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROWN STAIN IN SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1545026 SYRINGE 50ML LL PRECISE SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 1049923

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown