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

Model Number	381423
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Used 22ga insyte autoguard iv catheter for piv [peripheral iv] insertion.After insert iv, tried to retract the needle but was not working.

• Brand Name: BD INSYTE AUTOGUARD
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 24741441
• Report Number: 24741441
• Device Sequence Number: 9230313
• Product Code: FOZ
• UDI-Device Identifier: 00382903814237
• UDI-Public: (01)00382903814237
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2026
• Report Date (Section F): 03/26/2026

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
• Device Model Number: 381423
• Device Catalogue Number: 381423
• Device Lot Number: 5265765
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 03/31/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/26/2026