BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL

    MDR report key: 11743406 · Received April 29, 2021

    Report

    Report Number
    3003152976-2021-00238
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    March 31, 2021
    Report Date
    June 16, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 2021-05-26. H6: INVESTIGATION SUMMARY: TWO PHOTOS AND SEVERAL SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, OBSERVING EXCESS SILICONE IN ONLY ONE OF THE SAMPLES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2101049, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. LUBRICANT IS EMPLOYED DURING THE SYRINGE ASSEMBLY PROCESS TO LUBRICATE THE CYLINDERS IN THE SILICONE STATION. THE SILICONE EMPLOYED IN THIS PRODUCT IS A MEDICAL GRADE SILICONE AUTHORIZED FOR PRODUCT USE. SILICONE CONTENT TESTS ARE PERFORMED DURING THE MANUFACTURING PROCESS OF EACH LOT NUMBER. RESULTS WERE REVIEWED FOR LOT 2101049 AND FOUND TO BE WITHIN SPECIFICATION. TESTING WAS ALSO PERFORMED ON THE RETURNED SAMPLES, RESULTS VERIFIED THE AMOUNT OF SILICONE WAS ABOVE THE SPECIFIED LIMITS IN THE ONE SAMPLE, ALL OTHER PRODUCT WAS WITHIN SPECIFICATIONS. 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, THIS INCIDENT WAS DETERMINED TO HAVE OCCURRED DUE TO A FAILURE IN THE SPRAYER THAT DOES THE SILICONE WITHIN THE BARREL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 SYRINGE 10ML LL EXPERIENCED FOREIGN MATTER IN SYRINGE OR ANY FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A LARGE AMOUNT OF CLEAR SUBSTANCE IS VISIBLE INSIDE THE SYRINGE. RISK OF THIS BEING INJECTED INTO THE PATIENT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 SYRINGE 10ML LL EXPERIENCED FOREIGN MATTER IN SYRINGE OR ANY FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A LARGE AMOUNT OF CLEAR SUBSTANCE IS VISIBLE INSIDE THE SYRINGE. RISK OF THIS BEING INJECTED INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640105 SYRINGE 10ML LL SYRINGE FMF BECTON DICKINSON, S.A. 2101049

    Patients

    Seq Age Sex Outcome Treatment
    1