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

Model Number	3266
Health Effect - Clinical Codes	Pain (1994); Needle Stick/Puncture (2462)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Ongoing difficulty with icu medical/"jelco" brand peripheral intravenous catheters, poor blood return/"flashback", patient complaint of pain at site, multiple attempts to start iv, requires 2 hands for insertion.This is the central theme we are tracking and trending for [redacted] hospital with approximately 50 events reported by various experienced nurses across multiple departments (er, med/surg, l&d [labor and delivery], atu [admission transfer unit]).

• Brand Name: JELCO
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 24965203
• Report Number: 24965203
• Device Sequence Number: 18757948
• 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
• Device Catalogue Number: 3260
• Device Lot Number: 6183132
• 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: 04/23/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2026
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Date Report Sent to FDA: 04/14/2026