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

Catalog Number	326710
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
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 reportable information becomes available.
Event or Problem Description
It was reported that when the catheter was flushed with saline, the saline came out where catheter meets hub.There was patient involvement and there was no patient harm.There was medical intervention-iv removal and restart.Outcome of the event was resolved.Age of the patient is 64 years old.
Additional Manufacturer Narrative
This complaint was incorrectly filed under this registration number, please reference mrn 3012307300-2025-13790-00 for details pertinent to this event.

• Brand Name: JELCO VIAVALVE SAFETY IV CATHETER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st; southington CT 06489
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23517740
• Report Number: 1219611-2025-00014
• Device Sequence Number: 15886065
• Product Code: FOZ
• UDI-Device Identifier: 15019517078435
• UDI-Public: (01)15019517078435(17)270718(10)6138976
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K160235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

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: Lay User/Patient
• Device Catalogue Number: 326710
• Device Lot Number: 6138976
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2025
• 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