BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LS SP120

    MDR report key: 12271645 · Received August 3, 2021

    Report

    Report Number
    3003152976-2021-00449
    Event Type
    Malfunction
    Date Received
    August 3, 2021
    Date of Event
    July 6, 2021
    Report Date
    October 14, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-10-14. H6: INVESTIGATION SUMMARY: ONE SAMPLE RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION OF THE DEVICE, FOREIGN MATTER CAN BE SEEN. SYRINGE WAS DISASSEMBLED TO EXPLORE THE PARTS SEPARATELY, FINDING THE FOREIGN MATTER NOTICED BY CUSTOMER WAS EMBEDDED IN THE PLUNGER. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2011076 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. POSSIBLE ROOT CAUSE DUE TO THE INJECTION OF BURNT MATERIAL GENERATED DURING MOLDING PROCESS. BEFORE THE INJECTION MACHINE IS RESTARTED UP IT IS PURGED UNTIL DE MATERIAL IS ACCEPTABLE REJECTING THE FIRST PIECES. INJECTION MACHINES ARE PERIODICALLY SUBJECTED TO MAINTENANCE AND CLEANING PROGRAM. MOLDING PROCESS PARAMETERS REGISTERED IN THE DEVICE HISTORY RECORD REVIEW HAVE BEEN REVIEWED AND ALL OF THEM WERE SET WITHIN VALIDATED PROCESS. BASED ON THE INVESTIGATION RESULTS, NO MANUFACTURING RELATED DEFECTS COULD BE IDENTIFIED THEREFORE, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 1ML LS SP120 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT FOREIGN MATTER IN BARREL. THE CUSTOMER USES THIS PRODUCT FOR COVID VACCINATION. ACCORDING TO THE CUSTOMER'S REPORT, A BLACK STAIN WAS FOUND ON THE INNER SURFACE OF THE BARREL.

    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 1ML LS SP120 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT FOREIGN MATTER IN BARREL. THE CUSTOMER USES THIS PRODUCT FOR COVID VACCINATION. ACCORDING TO THE CUSTOMER'S REPORT, A BLACK STAIN WAS FOUND ON THE INNER SURFACE OF THE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163699 SYRINGE 1ML LS SP120 SYRINGE FMF BECTON DICKINSON, S.A. 2011076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown