BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE

    MDR report key: 24145474 · Received January 22, 2026

    Report

    Report Number
    9610048-2026-00006
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    January 13, 2026
    Report Date
    March 12, 2026
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903883110
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 388314 AND LOT NUMBER 3082664. 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, TWO (2) PICTURES AND ONE (1) REFERENCE VIDEO SAMPLE SHOWING A PINK INSYTE WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. WITHIN THE VIDEO, THE CATHETER WAS REMOVED FROM THE CANNULA, AND THE CUSTOMER SLIDES IT TO DEMONSTRATE THE CANNULA¿S SILICONIZATION. THROUGH ANALYSIS, NO EXCESS SILICONE WAS IDENTIFIED. THE SILICONE IS APPLIED IN ORDER TO FACILITATE THE SLIDING OF THE CATHETER OVER THE NEEDLE DURING PUNCTURE, REDUCE FRICTION, AND PROVIDE A SMOOTHER INSERTION, THUS DECREASING PATIENT DISCOMFORT. THEREFORE, THIS DOES NOT CONSTITUTE THE PRESENCE OF FOREIGN MATTER OR CONTAMINATION. BASED ON THE INVESTIGATION RESULTS, A MANUFACTURING RELATED ISSUE COULD NOT BE DETERMINED FOR THE REPORTED INCIDENT. 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

    IT WAS REPORTED THAT THE INSYTE CATHETERS HAVE LIQUID IN THE PROBE, WHICH THEY DO NOT NORMALLY HAVE. IMAGES, VIDEOS, AND PRODUCT BATCHES ARE ATTACHED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209553 INSYTE PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 3082664 00382903883110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown