BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *NS* INSYTE AUTOGUARD BL 22GA X 1.0IN

    MDR report key: 9695371 · Received February 11, 2020

    Report

    Report Number
    9610048-2020-00016
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Date of Event
    January 13, 2020
    Report Date
    January 21, 2020
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    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 · 1

    INVESTIGATION SUMMARY: THIS COMPLAINT DOES NOT CONTAIN SAMPLES OR PHOTOS FOR DETAILED ANALYSIS. IN ADDITION TO NO RECORDS THAT COULD CAUSE THIS COMPLAINT DURING THE BATCH HISTORY ANALYSIS, CORRECTIVE MAINTENANCE, NO CHANGES WERE REQUIRED AT THIS TIME AND THE TREND OF THE DEFECT WILL BE MONITORED AS A QDA MEETING. DHR REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED. THERE ARE NO QUALITY NOTIFICATION (QN) OR NONCONFORMITY REPORT OF "DAMAGED COMPONENT", ¿TRANSFIXED CATHETER¿ OR ANYTHING THAT COULD LEAD TO THIS COMPLAINT. INVESTIGATION CONCLUSION: NOT CONFORMED: BD WAS UNABLE TO CONFIRM THE CLAIM. ROOT CAUSE DESCRIPTION: BASED ON THE RESULTS OF THE INVESTIGATION SO FOR A ROOT CAUSE HAS NOT BEEN DETERMINED FOR THE DEFECT OF THIS COMPLAINT. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSYTE AUTOGUARD BL 22GA X 1.0IN WAS FOUND TO HAVE FOREIGN MATTER IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH. VERBATIM: ¿THE PRODUCT IS DIRTY BETWEEN THE CANNON AND THE NEEDLE, INVOLVING THE SAFETY DEVICE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160226 *NS* INSYTE AUTOGUARD BL 22GA X 1.0IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 381823 9224590 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other