BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 LL ECLIPSE

    MDR report key: 9660492 · Received February 3, 2020

    Report

    Report Number
    3003916417-2020-00023
    Event Type
    Malfunction
    Date Received
    February 3, 2020
    Date of Event
    January 13, 2020
    Report Date
    February 27, 2020
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    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: BASED ON THE INCIDENT IN QUESTION THE BATCH HISTORY WAS ANALYZED. SPECIFICALLY FOR FOREIGN MATTER, VISUAL INSPECTIONS OF THE PACKAGED PRODUCT ARE CARRIED OUT ACCORDING TO CONTROL PLAN, VALIDATED WITH THE ACCEPTABLE QUALITY LEVEL 0,10% (NQA) WITH THE FREQUENCY OF 2 HOURS AND ALWAYS ANALYZING 1 MACHINE CYCLE. ALL RECORDS OF THE MANUFACTURE OF THE LOT PRESENTED RESULTS IN ACCORDANCE WITH THE SPECIFICATION. AFTER THE EVALUATION OF THE SAMPLE IT WAS POSSIBLE TO OBSERVE FOREIGN MATTER ¿ CANNULA AT PACKAGING. THIS OCCURRENCE IS POSSIBLY ASSOCIATED WITH A FAILURE IN THE STAGE OF ASSEMBLY OF THE CANNULA ON THE NEEDLE WHERE THE EXCESS CANNULA REMAINED ADHERED TO THE ASSEMBLED MATERIAL, MOVING TO THE PACKAGING PROCESS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A NEEDLE 18X1-1/2 LL ECLIPSE . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "FOREIGN MATTER (NEEDLE EXTRA BENT) INSIDE THE PACKAGE".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 FOREIGN MATTER WAS FOUND BEFORE USE WITH A NEEDLE 18X1-1/2 LL ECLIPSE . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "FOREIGN MATTER (NEEDLE EXTRA BENT) INSIDE THE PACKAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126217 NEEDLE 18X1-1/2 LL ECLIPSE NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA 9088958

    Patients

    Seq Age Sex Outcome Treatment
    1 Other