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	08/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during insertion of the jelco viavalve safety iv catheter, blood was observed oozing from the needle guard upon placement of the peripheral intravenous (piv) catheter.There was patient involvement with no harm.
Additional Manufacturer Narrative
No sample was returned for evaluation.Two photographs were received for analysis.The first photograph showed the catheter inserted into the vein with the nose and device still attached to the hub.Blood was visible within the catheter hub, within the device beyond the nose, and externally on the patient.The second photograph showed the catheter inserted into the vein with only the hub remaining attached.Blood was visible within the hub and on the patient's skin surrounding the insertion site.A device history record (dhr) review confirmed that all required manufacturing inspections were completed and no abnormalities were identified.Based on the available photographic evidence, a definitive root cause could not be determined.

• 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: 50873277
• Report Number: 1219611-2026-00059
• Device Sequence Number: 13067267
• Product Code: FOZ
• UDI-Device Identifier: 15019517078398
• UDI-Public: (01)15019517078398(17)280512(10)6202845
• Combination Product (Y/N): N
• Initial Reporter State: NA
• 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
• Report Date (Section B): 09/23/2026

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: Other
• Device Catalogue Number: 326010
• Device Lot Number: 6202845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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