MAUDE Adverse Event Report: ICU MEDICAL, INC. JELCO; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	3266
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
When the nurse was inserting an iv catheter into the patients arm, she advanced the catheter as is standard procedure and blood began pouring out.The valve inside that is supposed to stop the blood from coming back out of the catheter failed.The catheter was removed and the procedure had to be redone with another catheter with a properly functioning valve.

• Brand Name: JELCO
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr; salt lake city UT 84123
• MDR Report Key: 24953013
• Report Number: 24953013
• Device Sequence Number: 17459295
• Product Code: FOZ
• UDI-Device Identifier: 15019517078428
• UDI-Public: (01)15019517078428
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/07/2026
• Report Date (Section F): 04/07/2026

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: 3266
• Device Catalogue Number: 3266
• Device Lot Number: 6177784
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2026
• 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: Unknown
• Date Report Sent to FDA: 04/07/2026