BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 24830214 · Received April 9, 2026

    Report

    Report Number
    1710034-2026-00385
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    March 14, 2026
    Report Date
    March 23, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825448
    PMA / PMN Number
    SEE H.11
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G.4. K201075; K251654. THE COMPLAINT OF A DAMAGED CATHETER WAS CONFIRMED FROM THE PHOTOGRAPHS THAT WERE PROVIDED FOR INVESTIGATION; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. FOUR PHOTOGRAPHS WERE RECEIVED FOR INVESTIGATION. ONE PHOTOGRAPH SHOWED TWO 18G INSYTE AUTOGUARD IV CATHETERS LAYING SIDE BY SIDE. ONE IV CATHETER CONTAINED WHAT APPEARED TO BE BLOOD RESIDUE IN THE CATHETER ADAPTER AND THE LENGTH OF THE CATHETER TUBING WAS SHORTER THAN THE OTHER IV CATHETER, WHICH APPEARED TO BE UNUSED. ANOTHER PHOTOGRAPH DISPLAYED A RADIOGRAPHIC IMAGE, THAT SHOWED WHAT COULD BE CONSISTENT WITH A FRAGMENT OF TUBING INSIDE THE PATIENT. THIS TYPE OF DAMAGE CAN OCCUR DURING THE INSERTION PROCESS IF THE CATHETER TUBING IS DAMAGED BY THE NEEDLE; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED FROM THE PHOTOGRAPH. THE INSTRUCTIONS FOR USE (IFU) WARNS, "IF THE NEEDLE IS PARTIALLY OR COMPLETELY WITHDRAWN FROM THE CATHETER TUBING DURING INSERTION, DO NOT RE-INSERT THE NEEDLE INTO THE CATHETER TUBING AS DAMAGE MAY OCCUR." THE COMPLAINT OF NEEDLE RETRACTION FAILURE COULD NOT BE CONFIRMED, SINCE THE SUPPLIED PHOTOGRAPHS DID NOT DISPLAY THE NEEDLE OF THE DEVICE. THE COMPLAINTS HAVE BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. COMPLAINTS RECEIVED ABOUT THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE DATA COLLECTED FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    CUSTOMER STATED: PT WAS LYING IN BED; NURSES WERE PERFORMING AN EKG. ATTEMPTED TO PUT A PERIPHERAL INTRAVENOUS CATHETER TO RIGHT ARM. DURING INSERTION THERE WAS AN IMMEDIATE BLOOD FLASH AND THE PIV CATHETER ADVANCED WELL, THE BUTTON ON THE 18G LOT NUMBER 4162541 DID NOT RETRACT WHEN PUSHED AND HAD TO PULL TO REMOVE THE NEEDLE. THE PIV HAD BLOOD RETURN, BUT WHEN IT FLUSHED THE PIV INFILTRATED. UPON REMOVAL OF THE PIV CATHETER, IT WAS DIFFICULT TO REMOVE. SO, WE PULLED OUT THE PIV WITH SOME FORCE AND PLACED 2 X 2 WITH COBAN WRAP TO COMPRESS THE SITE. UPON INSPECTION OF THE PIV CATHETER, IT WAS NOTICEABLE THAT THE CATHETER WAS BROKEN AT THE TIP AND WAS COMPARED TO AN OPENED PIV TO VERIFY. ALSO INFORMED DR. HE ORDERED AN XRAY AND VERIFIED THERE IS A PIECE OF THE CATHETER IN PTS ARM. ADDITIONAL INFORMATION 3/23/2026: CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT? (B)(6) 2026 AND PATIENT RETUNED TO THE FACILITY ON (B)(6) 2026. WHAT WAS THE IMPACT TO THE PATIENT? PIECE OF TIP OF CATHETER REMAINS IN SOFT TISSUE SPAC. ADDITIONAL INFORMATION 4/6/2026: HOW WAS THE IV CATHETER REMOVED FROM THE PATIENT? USING STANDARD PROCEDURE OR PULLING THE IV STRAIGHT OUT OF THE PLACEMENT SITE, HOLDING PRESSURE ON THE SITE FOR ANY BLEEDING AND THEN APPLYING A DRESSING WITH COBAN. POST WITHDRAWAL OF THE CATHETER, THE TIP IS INSPECTED BY THE CLINICIAN. PROVIDE ANY ADDITIONAL INFORMATION REGARDING ANY OTHER DIAGNOSTICS OR TREATMENT DIRECTLY RELATED TO THIS REPORTED ISSUE. FAMILY IS SEEKING SURGICAL CONSULT AT ANOTHER FACILITY TO HAVE THE TIP REMOVED. WE DO NOT PROVIDE SURGICAL SERVICES AT OUR FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893310 INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4162541 00382903825448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other