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	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspected event sample was not returned for evaluation; investigation cannot be performed.Lot history was reviewed.There were no discrepancies noted relevant to the indicated failure.The reported event was not confirmed.The root cause could not be determined.
Event or Problem Description
It was reported that the viap w 20g x 1 1/4 200/ca was involved in an event where a practitioner was initiating a 20g iv on a patient in the back of an ambulance while still on scene.Once the catheter was advanced into the vein, the needle reportedly failed to retract properly and lock into the safety casing.During attempts to manage the iv(intra-venous), the back plastic chamber on the iv casing became detached.As a result, blood reportedly sprayed several feet from the iv site and spilled onto the floor in front of the patient, who was seated in the airway chair.Leaking of blood from the via valve catheter exposed the patient and health care professional to the blood borne pathogens.There was patient involvement, and no harm.

• 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25279531
• Report Number: 3012307300-2026-05379
• Device Sequence Number: 15967390
• Product Code: FOZ
• UDI-Device Identifier: 10351688081957
• UDI-Public: (01)10351688081957(17)271105(10)6166821
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

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: 328600
• Device Lot Number: 6166821
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2025
• 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