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	07/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during iv catheter insertion, after the needle was inserted and the catheter advanced, blood continued to flow into the flashback chamber, along the sides of the device, and into the needle hub.Following successful iv insertion with positive flashback, the iv device was removed from the catheter; however, blood continued to flow from the catheter in the patient's extremity, indicating that the blood control feature may not have functioned as intended.The issue was observed by using iv catheters from the same box.A catheter from a different box (different lot number) was subsequently used, and the blood control feature functioned as expected, with no blood flow observed from the catheter after removal of the iv device and without distal pressure applied.There was patient involvement and no patient harm.
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.

• Brand Name: Jelco ViaValve Safety IV Catheter
• Common Device Name: Catheter, Intravascular, Therapeutic, Short-Term
• Manufacturer (Section D): ICU Medical, Inc.; 201 west queen st; southington CT 06489
• Manufacturer Contact: reed covert ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50479693
• Report Number: 1219611-2026-00024
• Device Sequence Number: 21366392
• Product Code: FOZ
• UDI-Device Identifier: 15019517078398
• UDI-Public: (01)15019517078398(17)280515(10)6202848
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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: 326010
• Device Lot Number: 6202848
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 08/27/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2026
• 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