BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML W/SND CURITBA

    MDR report key: 9162323 · Received October 7, 2019

    Report

    Report Number
    3003916417-2019-00505
    Event Type
    Malfunction
    Date Received
    October 7, 2019
    Date of Event
    September 13, 2019
    Report Date
    October 22, 2019
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: DHR, MAINTENANCE RECORD ANALYSIS AND QUALITY NOTIFICATION ANALYSIS WERE PERFORMED AND NO DEVIATIONS WERE FOUND FOR THIS BATCH. SAMPLES OF REPORTED INCIDENT WERE RECEIVED FOR ANALYSIS. THESE SAMPLES WERE SUBMITTED TO EVALUATION ACCORDING BD PROCEDURES GQ 168 0 IMW AND GQ 187 0 IMW AND NO DEVIATIONS WERE OBSERVED. THE MANUFACTURING PROCESS ARE VALIDATED WITH DEFINED ACCEPTANCE CRITERIA. FROM THIS INFORMATION IT IS NOT POSSIBLE CONFIRM THE COMPLAINT. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 10ML W/SND CURITBA EXPERIENCED SYRINGE -VOLUMETRIC ACCURACY ISSUES WHICH WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ITEMS BELOW DID NOT MEET THE REQUIREMENTS OF THE STANDARD. - THE 32 SAMPLE PISTONS DO NOT MATCH THE ZERO SCALE GRADUATION LINE WHEN THEY ARE FULLY INSERTED.

    Additional Manufacturer Narrative · 1

    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 THAT AN UNSPECIFIED NUMBER OF SYRINGE 10ML W/SND CURITBA EXPERIENCED SYRINGE -VOLUMETRIC ACCURACY ISSUES WHICH WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ITEMS BELOW DID NOT MEET THE REQUIREMENTS OF THE STANDARD. THE 32 SAMPLE PISTONS DO NOT MATCH THE ZERO SCALE GRADUATION LINE WHEN THEY ARE FULLY INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958683 SYRINGE 10ML W/SND CURITBA SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 8068550

    Patients

    Seq Age Sex Outcome Treatment
    1 Other