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

Catalog Number	326610
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown; no information has been provided to date.H3/h6: investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was stated that when the nurse was inserting an iv catheter into the patient¿s arm, they advanced the catheter as is standard procedure and blood began pouring out.The valve inside that supposed to stop the blood from coming back out of the catheter failed.There was a patient involvement and there was no reported patient harm.
Additional Manufacturer Narrative
E4 - initial report sent to fda was updated.H6 codes were updated.The suspected device was not received for evaluation.The device history file was reviewed.There were no nonconformities were identified that may have contributed to the reported complaint.The complaint cannot be replicated or confirmed, and a root cause was unable to be determined.A good faith effort was conducted to retrieve the device from the customer.

• 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: 25162244
• Report Number: 3012307300-2026-04946
• Device Sequence Number: 16113726
• Product Code: FOZ
• UDI-Device Identifier: 15019517078428
• UDI-Public: (01)15019517078428(17)271230(10)6177784
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2026

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: 326610
• Device Lot Number: 6177784
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2026
• 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