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

Model Number	3266
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Rn attempted to placed iv in patient's forearm, but was unable to redirect the needle without blowing vein with new iv catheters.This resulted in the patient being poked multiple times for a successful iv access.Per rn, the company representative states the catheters are too sharp and are unable to be redirected like our old catheters.Per staff and nursing leaders, multiple staff including experienced rns with >20 years of bedside experience are reporting concerns that they have never had such difficulties requiring multiple attempts for iv access with any other brand of iv catheters in their career.Multiple rns and patients have reported safety concerns with this new brand of iv catheters.

• 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: 24965431
• Report Number: 24965431
• Device Sequence Number: 10496564
• Product Code: FOZ
• UDI-Device Identifier: 15019517078428
• UDI-Public: (01)15019517078428
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 04/14/2026
• Report Date (Section F): 04/14/2026

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/14/2026