MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY INSYTE AUTOGUARD; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	381934
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
When inserting the iv, the tip of the iv went in, but unable to advance further.2nd iv attempted with different lot number without difficulty and iv was successfully placed.Other staff reported several instances of same issue with iv catheters.

• Brand Name: INSYTE AUTOGUARD
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 17200 laguna canyon rd; irvine CA 92618
• MDR Report Key: 25592458
• Report Number: 25592458
• Device Sequence Number: 20203905
• Product Code: FOZ
• UDI-Device Identifier: 00382903819348
• UDI-Public: 00382903819348
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/19/2026
• Report Date (Section F): 06/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 381934
• Device Catalogue Number: 381934
• Device Lot Number: 5302107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/23/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 06/19/2026