BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE

    MDR report key: 18307633 · Received December 11, 2023

    Report

    Report Number
    9610048-2023-00114
    Event Type
    Malfunction
    Date Received
    December 11, 2023
    Date of Event
    September 29, 2023
    Report Date
    March 21, 2024
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    UKN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. 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

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38831114 AND LOT NUMBER 3082672. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR THIS EVENT, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. ALTHOUGH AN EXACT CAUSE COULD NOT BE IDENTIFIED FOR THIS INCIDENT, A CORRECTIVE AND PREVENTIVE ACTION PLAN HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE AND PREVENT ANY REOCCURRENCE. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS. SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE NEEDLE PIERCED THE CATHETER THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: DELAY IN TREATMENT DUE TO NEEDLE PENETRATION DIFFICULT, AND MANDREL TRANSFIXION WITH SILICON CATHETER. CUTANEOUS INJURY AND EDEMA IN UPPER AND LOWER LIMBS

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111919 BD INSYTE PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 3082672

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown