BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL CONVENIENCE TRAY EUROPE

    MDR report key: 12416377 · Received September 2, 2021

    Report

    Report Number
    3003152976-2021-00542
    Event Type
    Malfunction
    Date Received
    September 2, 2021
    Date of Event
    August 4, 2021
    Report Date
    October 28, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-09-21. H6: INVESTIGATION SUMMARY ONE CONVENIENCE PACK REFERENCE 302238 AND LOT NUMBER 2101073 RECEIVED FOR INVESTIGATION. LOTS 2103099 AND 2102092 WERE ALSO CLAIMED BUT NO SAMPLES ARE AVAILABLE. UPON VISUAL INSPECTION OF THE SYRINGES, IT CAN BE OBSERVED THE MATERIAL IS TRANSPARENT AND CORRECTLY MOLDED. NO HITS IN THE BARREL CAN BE OBSERVED. DAMAGE IN THE FLANGE, NEAR THE BOTTOM OF THE SYRINGE CAN BE SEEN. IN THIS PART OF THE SYRINGE THERE IS A CIRCUMFERENCE AROUND THE BARREL CAUSED BY THE MARKING MACHINE, WHEN THE SYRINGE IS POSITIONED TO STAMP THE SCALE. THIS PROCESS, CAN LEAVE A LIGHT MARK IN THE BARREL THAT CAN BE RELATED WITH THE DEFECT DESCRIBED BY CUSTOMER. A DEVICE HISTORY REVIEW WAS PERFORMED AND FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF LOTS 2101073, 2103099 AND 2102092 ALL PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATION. POSSIBLE ROOT CAUSE IS ASSOCIATED WITH THE MARKING PROCESS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE SYRINGE 50ML LL CONVENIENCE TRAY EUROPE THERE WAS A DAMAGED/DEFORMED PRODUCT - DEVICE IS OPERABLE AND FOREIGN MATTER IN THE SYRINGE OR ANY FLUID PATH COMPONENT. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN OPENING THE 50 ML PLASTIPACK CONVENIENCE PACK IT IS NOTED THAT THE SYRINGES APPEAR BATTERED AND CLOUDY."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2101073. MEDICAL DEVICE EXPIRATION DATE: 2025-12-31. DEVICE MANUFACTURE DATE: 2021-01-15. MEDICAL DEVICE LOT #: 2103099. MEDICAL DEVICE EXPIRATION DATE: 2026-02-28. DEVICE MANUFACTURE DATE: 2021-03-24. MEDICAL DEVICE LOT #: 2102092. MEDICAL DEVICE EXPIRATION DATE: 2026-01-31. DEVICE MANUFACTURE DATE: 2021-02-25. 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 WHEN USING THE SYRINGE 50ML LL CONVENIENCE TRAY EUROPE THERE WAS A DAMAGED/DEFORMED PRODUCT - DEVICE IS OPERABLE AND FOREIGN MATTER IN THE SYRINGE OR ANY FLUID PATH COMPONENT. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN OPENING THE 50 ML PLASTIPACK CONVENIENCE PACK IT IS NOTED THAT THE SYRINGES APPEAR BATTERED AND CLOUDY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1315794 SYRINGE 50ML LL CONVENIENCE TRAY EUROPE SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown