BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL 120/PKG

    MDR report key: 10119377 · Received June 4, 2020

    Report

    Report Number
    3002682307-2020-00181
    Event Type
    Malfunction
    Date Received
    June 4, 2020
    Date of Event
    May 14, 2020
    Report Date
    June 11, 2020
    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 UPDATED DUE TO ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2020-06-03. INVESTIGATION SUMMARY: ONE SAMPLE PROVIDED TO OUR QUALITY ENGINEER FOR INVESTIGATION. UPON VISUALLY INSPECTING THE PRODUCT, DAMAGE ON THE BARREL THREAD WAS OBSERVED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF LOT 2001288. THE AREAS WHERE PIECES RUN IN MANUFACTURING AREA ARE PROTECTED TO AVOID DAMAGE ON THE PRODUCT. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE AND LOT SIZE 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 THE DAMAGE WAS LIKELY CAUSED AS A RESULT OF THE PRODUCT JAMMING WITHIN THE MANUFACTURING EQUIPMENT. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 20ML LL 120/PKG CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UNABLE TO CONNECT THE NEEDLE TO THE SYRINGE DUE TO THE PRESENCE OF PLASTICS (FADES) INTO THE LUER LOCK OF THE SYRINGE."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 20ML LL 120/PKG CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UNABLE TO CONNECT THE NEEDLE TO THE SYRINGE DUE TO THE PRESENCE OF PLASTICS (FADES) INTO THE LUER LOCK OF THE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585539 SYRINGE 20ML LL 120/PKG SYRINGE FMF BECTON DICKINSON, S.A. 2001288

    Patients

    Seq Age Sex Outcome Treatment
    1 Other