MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOGUARD IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	381444
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Iv fluids was hooked up to cathlon, it was leaking.Fluids were changed hoping it was from the iv tubing.Iv was still leaking.Fluids removed and hook up to j-loop(iid) and flush, still leaking.Once we were able to examine the green cathlon, we noticed that part of the hub was broken and it was never going to seal.

• Brand Name: INSYTE AUTOGUARD IV CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
• MDR Report Key: 16583301
• Report Number: MW5115859
• Device Sequence Number: 17676922
• Product Code: FOZ
• UDI-Device Identifier: 00382903814442
• UDI-Public: (01)00382903814442
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/16/2023

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 Expiration Date: 08/31/2025
• Device Model Number: 381444
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown