BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL

    MDR report key: 11963339 · Received June 8, 2021

    Report

    Report Number
    3003152976-2021-00321
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    May 12, 2021
    Report Date
    August 2, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE CORRECTED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL NO. D10: RETURNED TO MANUFACTURER ON: NA. H6: INVESTIGATION SUMMARY ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED AND THE STOPPER WAS VERIFIED TO BE INCORRECTLY ASSEMBLED, PARTIALLY DETACHED FROM THE PLUNGER ROD. THERE ARE NO OTHER VISIBLE DEFECTS THAT COULD HAVE CONTRIBUTED TO THE ISSUE OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2011040, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. 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. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS INCIDENT OCCURRED AS A RESULT OF IMPROPER ALIGNMENT OF THE PLUNGER/STOPPER TO THE BARREL DURING ASSEMBLY. A CAMERA SYSTEM IS USED IN THE ASSEMBLY MACHINE TO DETECT MISSING OR IMPROPERLY ASSEMBLED STOPPERS. THERE WERE NO INCIDENTS DOCUMENTED RELATED TO ANY FAILURES WITH THE DETECTION SYSTEM, THEREFORE WE CANNOT IDENTIFY WHY THE IMPACTED SAMPLE WAS NOT DISCARDED. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 50ML LL PISTON WAS IN THE WRONG POSITION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PISTON IN WRONG POSITION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 PISTON WAS IN THE WRONG POSITION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PISTON IN WRONG POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850416 SYRINGE 50ML LL SYRINGE FMF BECTON DICKINSON, S.A. 2011040

    Patients

    Seq Age Sex Outcome Treatment
    1