BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 50ML LL CONVENIENCE TRAY EUROPE

    MDR report key: 12849118 · Received November 19, 2021

    Report

    Report Number
    3003152976-2021-00771
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Date of Event
    October 22, 2021
    Report Date
    December 14, 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

    H6: INVESTIGATION SUMMARY : ONE SAMPLE RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION OF THE SYRINGE, IT CAN BE OBSERVED THE MATERIAL IS TRANSPARENT AND CORRECTLY MOLDED. NO HITS IN THE BARREL CAN BE OBSERVED. DAMAGE IN THE BARREL, NEAR TO THE WINGS 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. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2103099, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. POSSIBLE ROOT CAUSE IS ASSOCIATED WITH THE MARKING PROCESS. THIS PROCESS, CAN LEAVE A LIGHT MARK IN THE BARREL THAT CAN BE RELATED WITH THE DEFECT DESCRIBED BY CUSTOMER. 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. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT BD SYRINGE 50ML LL CONVENIENCE TRAY EUROPE WAS DAMAGED, BUT STILL OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER FROM HOSPITAL PHARMACY REPORTS: ONCE OPENING THE 50 ML PLASTIPACK CONVENIENCE PACK IT IS NOTED THAT THE SYRINGES APPEAR BATTERED AND WITH GREY SCRATHES."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 50ML LL CONVENIENCE TRAY EUROPE WAS DAMAGED, BUT STILL OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER FROM HOSPITAL PHARMACY REPORTS: ONCE OPENING THE 50 ML PLASTIPACK CONVENIENCE PACK IT IS NOTED THAT THE SYRINGES APPEAR BATTERED AND WITH GREY SCRATHES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739813 BD SYRINGE 50ML LL CONVENIENCE TRAY EUROPE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2103099

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown