BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 23653733 · Received November 26, 2025

    Report

    Report Number
    9610048-2025-00177
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    October 13, 2025
    Report Date
    January 20, 2026
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    30382903818236
    PMA / PMN Number
    NA
    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 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 38182314 AND LOT NUMBER 5083552. 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) VIDEO SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE COMPLAINT OF A DAMAGED CATHETER WAS CONFIRMED FROM THE VIDEO THAT WAS PROVIDED FOR INVESTIGATION. THE NEEDLE WAS PROTRUDING THROUGH THE CATHETER TUBING, WHICH CAUSED THE CATHETER TIP TO BEND AWAY FROM THE NEEDLE AT THE PUNCTURE SITE. THE CATHETER APPEARED TO BE IN ONE PIECE AND NO DAMAGE COULD BE DISCERNED ON THE NEEDLE. AS THE DAMAGE WAS VERIFIED OUTSIDE ITS PACKAGING, IT COULD NOT BE DETERMINED IF THE DAMAGE OCCURRED DURING USE AND HANDLING OR DURING MANUFACTURING. A REVIEW OF THE INSPECTION RECORDS AND QUALITY/MANUFACTURING CONTROLS FOR THE IMPLICATED LOT INDICATED NO ISSUES WITH THE MANUFACTURING PROCESS. MANUFACTURING CONTROLS ARE IN PLACE TO MITIGATE THE OCCURRENCE OF THIS TYPE OF FAILURE. THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN HANDLING THE DEVICE ON THE PATIENT, THE SILICONE PART BREAKS, CAUSING THE PROCEDURE TO FAIL. ADDITIONAL INFORMATION RECEIVED ON 11NOV 2025: THE SAMPLE IS NOT AVAILABLE DUE TO THE MATERIAL HAVING INFECTIOUS RESIDUE. WE HAD A VERY HIGH VOLUME OF MATERIAL WITH QUALITY DEVIATION. THE MATERIAL CAUSED PAIN AT THE VENIPUNCTURE SITE DURING THE PUNCTURE AND POST-PUNCTURE AND INCREASED THE AMOUNT OF NEED FOR VENIPUNCTURE (MULTIPLE PUNCTURES).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2811855 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 5083552 30382903818236

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown