BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML W/SND

    MDR report key: 7075697 · Received December 1, 2017

    Report

    Report Number
    3003916417-2017-00089
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    November 7, 2017
    Report Date
    November 9, 2017
    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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE BATCH RECORDS, MAINTENANCE EVALUATION, AND QUALITY NOTIFICATION OF CATALOGUE 307859, LOT # 7132876 WERE EVALUATED. THERE ARE NO COMPLAINTS FOR THE SAME DEFECT, AND NO OCCURRENCES OR QUALITY NOTIFICATIONS IN THIS BATCH. WITHOUT THE SAMPLES OR PHOTOS IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THIS DEFECT. BASED ON NO SAMPLE/ NO PHOTO, THE INVESTIGATION CONCLUDED: BD WAS NOT ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE FAILURE MODE INDICATED BY THE CUSTOMER, OR THE DATA WERE INSUFFICIENT TO THE ANALYSIS. THE HISTORICAL RECORDS OF THE LOT IN QUESTION WERE EVALUATED, ALONG WITH THE MAINTENANCE EVALUATION AND QUALITY NOTIFICATION. WITHOUT SAMPLES OR PHOTOS IT WAS NOT POSSIBLE DETERMINE THE ROOT CAUSE FOR THIS DEFECT. PROBABLE CAUSES: WITHOUT SAMPLES OR PHOTOS IT WAS NOT POSSIBLE DETERMINE THE ROOT CAUSE FOR THIS DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE OF THE SYRINGE 3ML W/SND WITH A TOTAL OF 58 SYRINGES; 9% OF THE SYRINGES PRESENTED WITH IRREGULARITIES, OF THE TOTAL, 22% WITH DEEP AND LARGE CRACKS, 4% WITH GROOVES IN LOW RELIEF AND 3% WITH SMALL AND SLIGHT CRACKS. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853416 SYRINGE 3ML W/SND SYRINGE WITH NEEDLE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 7132876

    Patients

    Seq Age Sex Outcome Treatment
    1 Other