BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 22806012 · Received August 14, 2025

    Report

    Report Number
    1710034-2025-01340
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    July 18, 2025
    Report Date
    August 26, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 381834 AND LOT NUMBER 4222717. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE, AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    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.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE PIERCED THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON SEVERAL OCCASIONS, THE HEADS OF SERVICE HAVE REPORTED INCONVENIENCES RELATED TO THE QUALITY OF THE SUPPLIES. A JOINT FOLLOW-UP WITH THE PATIENT SAFETY REFERENT WAS CARRIED OUT, IN WHICH IT WAS EVIDENCED THAT THE HEALTH PERSONNEL HAVE AN ADEQUATE TECHNIQUE FOR THE INSERTION OF THE CATHETER. HOWEVER, DESPITE THE CORRECT APPLICATION OF THE PROCEDURE, THERE HAVE BEEN MULTIPLE DIFFICULTIES, SINCE IN MOST OF THE CASES WHERE THIS INPUT IS USED, VENOUS EXTRAVASATION HAS BEEN EVIDENCED. CASE 1 PATIENT IN THE HOSPITALIZATION SERVICE TRANSFERRED ON (B)(6) 2025 FROM THE EMERGENCY DEPARTMENT WITH AN IB #20 CATHETER, FOR MANAGEMENT OF HER CONDITION, ON (B)(6) 2025 IT IS VISUALIZED THAT SHE PRESENTS COLORATION, INFLAMMATION AND PAIN IN THE ACCESS POINT, WHICH REQUIRES INTERVENTION WITH PHYSICAL DOCTORS AND CHANGE OF THE ACCESS POINT, SITUATION PRESENTED AND REPORTED BY THE HEAD OF THE HOSPITALIZATION SERVICE. WHEN MANAGING THE CHANGE OF ACCESS, TWO DAYS LATER (B)(6) 2025) SHE PRESENTS AGAIN A SIMILAR CONDITION OF CELLULITIS IN THE ACCESS POINT, EXECUTING A CHANGE OF ACCESS AND THE SAME MANAGEMENT OF HER CONDITION, BUT THIS TIME WITH A DIFFERENT DEVICE WHICH FOLLOWS UP THE PATIENT WITHOUT SHOWING MORE AFFECTATIONS. THE PATIENT WAS TRANSFERRED TO ANOTHER INSTITUTION FOR LEVEL 3 MANAGEMENT WITHOUT FURTHER COMPLICATIONS. THE 2 UNITS INVOLVED IN THE REPORT WERE DISCARDED BY THE CARE STAFF PRIOR TO THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1686432 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4222717 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown