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

Model Number	382633
Health Effect - Clinical Codes	Extravasation (1842); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The iv catheter did not give any flash when inserting the iv until we went to take out the iv and at that point, we could not save the vein as it was almost out.

• 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: 21676141
• Report Number: 21676141
• Device Sequence Number: 8230451
• Product Code: FOZ
• UDI-Device Identifier: 00382903826339
• UDI-Public: (01)00382903826339
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/19/2025
• Report Date (Section F): 03/19/2025

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: 382633
• Device Catalogue Number: 382633
• Device Lot Number: 4352441
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 03/24/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2025
• 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
• Patient Sex: Female
• Date Report Sent to FDA: 03/19/2025