BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILL NEEDLE

    MDR report key: 13321243 · Received January 21, 2022

    Report

    Report Number
    3003916417-2022-00005
    Event Type
    Malfunction
    Date Received
    January 21, 2022
    Date of Event
    December 31, 2021
    Report Date
    March 4, 2022
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    GAA
    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 DEFAULTA 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. UPON VISUAL INSPECTION, IT IS POSSIBLE TO OBSERVE THE MEDICINE VIAL WITH SOME KIND OF FOREIGN MATERIAL INSIDE, BUT IT WAS NOT POSSIBLE TO OBSERVE THE NEEDLE, THEREFORE WE ARE UNABLE TO CONFIRM THE FAILURE. THE NEEDLE RELATED TO THIS CLAIM (NEEDLE 18GA 1IN BLUNT FILL SLA) IS AN ASPIRATION NEEDLE (BLUNT TIP), SO IT DOES NOT HAVE A THREE-SIDED TIP. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 1203794 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. 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. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ BLUNT FILL NEEDLE CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN INJECTING 05 ML OF 0.9% SF INTO THE MEDICATION VIAL USING A 25X12 NEEDLE WITH A SINGLE PERFORATION, A SMALL FRAGMENT OF THE RUBBER PART OF THE VIAL CAME OFF INSIDE THE SOLUTION, MAKING IT UNUSABLE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ BLUNT FILL NEEDLE CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " WHEN INJECTING 05 ML OF 0.9% SF INTO THE MEDICATION VIAL USING A 25X12 NEEDLE WITH A SINGLE PERFORATION, A SMALL FRAGMENT OF THE RUBBER PART OF THE VIAL CAME OFF INSIDE THE SOLUTION, MAKING IT UNUSABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1983519 BD¿ BLUNT FILL NEEDLE MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BECTON DICKINSON IND. CIRURGICAS LTDA 1203794

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown