BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PERFUSION 50 ML SYRINGE WITH MOUNTED NEEDLE, OPAQUE

    MDR report key: 13334150 · Received January 24, 2022

    Report

    Report Number
    3003916417-2022-00009
    Event Type
    Malfunction
    Date Received
    January 24, 2022
    Date of Event
    January 1, 2022
    Report Date
    March 14, 2022
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: PHOTOS RECEIVED FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1132504, A MAINTENANCE ORDER WAS EVIDENCED THAT COULD POTENTIALLY BE RELATED TO THE INCIDENT. POSSIBLE ROOT CAUSE IS ASSOCIATED WITH THE MISMATCH IN THE ROD RAIL. CORRECTIVE ACTIONS WERE TAKEN IMMEDIATELY TO ADJUST THE ROD RAIL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 6 BD PERFUSION 50 ML SYRINGES WITH MOUNTED NEEDLE, OPAQUE HAD A BROKEN PLUNGER ROD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I AM HEREBY COMMUNICATING ABOUT SOME SYRINGES THAT ARE DEFECTIVE, THEY BREAK WHEN THE PLUNGER IS PULLED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 6 BD PERFUSION 50 ML SYRINGES WITH MOUNTED NEEDLE, OPAQUE HAD A BROKEN PLUNGER ROD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I AM HEREBY COMMUNICATING ABOUT SOME SYRINGES THAT ARE DEFECTIVE, THEY BREAK WHEN THE PLUNGER IS PULLED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1983163 BD PERFUSION 50 ML SYRINGE WITH MOUNTED NEEDLE, OPAQUE PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 1132504

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown