BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 20ML

    MDR report key: 12264203 · Received August 2, 2021

    Report

    Report Number
    3002682307-2021-00374
    Event Type
    Malfunction
    Date Received
    August 2, 2021
    Date of Event
    July 6, 2021
    Report Date
    October 26, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1910231. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, THE AFFECTED SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH ANALYSIS OF THE SAMPLE, A BROWN PARTICLE WAS OBSERVED INSIDE THE TIP OF THE SYRINGE. THE BROWN PARTICLE HAS BEEN IDENTIFIED AS A RESIDUAL PARTICLE OF TEFLON. THIS PARTICLE WAS GENERATED WITHIN THE ASSEMBLY MACHINE. IN THE ASSEMBLY MACHINE THERE IS A SYRINGE TIP POSITIONER WHICH ALLOCATES THE BARRELS CORRECTLY TO BE INTRODUCED INTO THE MACHINE. THIS STATION IS SOMETIMES CORRECTED WITH TEFLON TAPE TO BE IN THE PERFECT POSITION FOR ALIGNMENT OF THE BARREL TRANSFER. WE HAVE CONCLUDED THAT A PARTICLE OF TEFLON DETACHED FROM THE MACHINE STATION AND ENDED UP ON THE REPORTED SYRINGE TIP. DESPITE THE FACT THAT THE HIGH-VOLUME MANUFACTURING PROCESS MAY GENERATE SOME PARTICULATE MATTER, BD KEEPS THE PARTICULATE MATTER TO EXTREMELY LOW LEVELS DUE TO THE STRINGENT PREVENTIVE MEASURES IN PLACE. WE ARE CONFIDENT THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY RECURRENCE. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CLOSELY MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE S2 20ML HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER INFORMS THAT THERE IS SOME BROWN DIRT OR STAIN IN THE TIP OF THE SYRINGE WHEN TAKING IT OUT FROM THE PACKET.

    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 S2 20ML HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER INFORMS THAT THERE IS SOME BROWN DIRT OR STAIN IN THE TIP OF THE SYRINGE WHEN TAKING IT OUT FROM THE PACKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159332 SYRINGE S2 20ML SYRINGE FMF BECTON DICKINSON, S.A. 1910231

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown