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

Catalog Number	328600
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Event or Problem Description
It was reported that the while the catheter was threaded into the vein, the valve did not work, and blood came out of the intravenous.There was patient involvement, no injury was reported.
Additional Manufacturer Narrative
Corrected: health effect - impact code, there was a patient involvement.No product was returned.The reported issue cannot be confirmed as no product was returned for investigation.If the product is returned, this complaint will be reopened for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
Additional Manufacturer Narrative
H3/h6: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.One unused device from the same lot were returned for investigation.The devices were visually inspected.There were no anomalies noted upon visual inspection.Simulated leakage testing using a wet vein pad was performed on the unused sample and no seal leakage was noted.Examination of the unused sample's seal component displayed no punctures or tears in the o.D.Or web i.D.Of the component.Based on device analysis, the complaint cannot be confirmed.Review of manufacturing logbooks identified no definitive root cause for the reported complaint.Without the actual device available for investigation, the probable cause for the complaint is indeterminate.

• Brand Name: JELCO VIAVALVE SAFETY IV CATHETER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ICU MEDICAL, INC.; 201 west queen st; southington CT 06489
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23513605
• Report Number: 3012307300-2025-12279
• Device Sequence Number: 9613504
• Product Code: FOZ
• UDI-Device Identifier: 10351688081957
• UDI-Public: (01)10351688081957(17)270408(10)6113404
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K160235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2026

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: Lay User/Patient
• Device Catalogue Number: 328600
• Device Lot Number: 6113404
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 12/09/2025; 02/04/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/17/2025; 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown