BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE

    MDR report key: 24038428 · Received January 12, 2026

    Report

    Report Number
    9610048-2025-00206
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 17, 2025
    Report Date
    March 11, 2026
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903883172
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38831714 AND LOT NUMBER 5051093. THE REVIEW DID NOT REVEAL ANY ABNORMALITIES DETECTED DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT, AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PICTURE SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURE, THE CATHETER WAS OBSERVED TRANSFIXED BY THE NEEDLE. IT IS POSSIBLE THAT THIS INCIDENT MAY BE RELATED TO PRODUCT ASSEMBLY. A FAILURE IN THE VISION SYSTEM DURING MANUFACTURING MAY ALLOW A TRANSFIXED CATHETER TO PASS THROUGH INSPECTION AND REACH THE CUSTOMER. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    FAILURE OF A CANNULA WE PURCHASED FROM YOU THIS YEAR. WHEN PUNCTURING THE PATIENT AND ATTEMPTING TO REMOVE THE CANNULA, WE NOTICED THAT IT WAS PERFORATED. ADDITIONAL INFORMATION RECEIVED ON 05JAN2026. IN RESPONSE TO YOUR INQUIRIES, I WOULD LIKE TO POINT OUT THAT I HAVE NO RECORD OF THE FIRST INCIDENT. WAS THERE ANY DAMAGE TO THE PATIENT'S HEALTH? IF SO, PLEASE EXPLAIN THE DETAILS. A: NO. WAS HOSPITALIZATION OR PROLONGED HOSPITALIZATION NECESSARY? PLEASE PROVIDE DETAILS. A: NO. WAS ANY MEDICAL AND/OR SURGICAL INTERVENTION NECESSARY DUE TO THE INCIDENT (IMAGING TESTS, SURGERY, ADMINISTRATION OF MEDICATION, ETC.)? PLEASE PROVIDE DETAILS. A: NO. COULD YOU CONFIRM THE DATE ON WHICH THE PROBLEM/DEFECT OCCURRED OR WAS IDENTIFIED? A: 12/17/2025 WAS THE DATE OF THE REPORT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101263 INSYTE PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 5051093 00382903883172

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown