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

Catalog Number	326700
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation however a device history review should be performed.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 there was spontaneous bleeding that occurred upon intravenous (iv) insertion.Reporter have had the concern brought forward by multiple staff members and was able to observe an insertion this morning where spontaneous bleeding occurred.There was patient involvement and no harm reported.

• 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 street; southington CT 06489
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24457141
• Report Number: 1219611-2026-00001
• Device Sequence Number: 9376070
• Product Code: FOZ
• UDI-Device Identifier: 15019517078435
• UDI-Public: (01)15019517078435(17)270108(10)6087972
• 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,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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 Catalogue Number: 326700
• Device Lot Number: 6087972
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown