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

Catalog Number	326010
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: codes were updated.One device was returned for investigation.Sample was visually evaluated for potential nonconformances and met product specification requirements for the reported complaint.Without the catheter assembly for the returned sample to evaluate for potential valve functionality issues, the probable cause for the reported complaint of leakage could not be determined and there was no evidence of foreign matter contamination in the received sample.A device history record review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Complaint information will continue to be monitored.Icu medical regularly reviews and analyzes post-market data for new information or adverse trends, implementing corrections, taking corrective and preventative actions accordingly.This file was originally incorrectly filed under registration number mrn 1219611-2024-00055-00.The date of that submission was 19-nov-2024.
Event or Problem Description
It was reported that while starting a peripheral iv, the writer noticed blood leaking from the hub after the needle was secured in the chamber.There was patient involvement, and no harm/adverse event reported.

• Brand Name: JELCO VIAVALVE SAFETY IV CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• 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: 23554849
• Report Number: 3012307300-2025-12473
• Device Sequence Number: 10160797
• Product Code: FOZ
• UDI-Device Identifier: 15019517078398
• UDI-Public: (01)15019517078398(17)260823(10)6037370
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2025

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 Expiration Date: 08/23/2026
• Device Catalogue Number: 326010
• Device Lot Number: 6037370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• 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