MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO VIAVALVE PUR WINGED CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM

Catalog Number	328000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle was retracted into the chamber and blood started leaking from the tip of the catheter.There was no patient harm reported as a result of the event.
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.
Additional Manufacturer Narrative
D9: 5/20/2025.One used sample was visually evaluated for potential nonconformances.There was no evidence of blood pooling into the guard and nose components and no cannula o.D.Or nose i.D.Gaping noted that could potentially result in the reported leakage.Dried blood residue was identified in the flashback chamber and showed normal evidence of flash.Without the catheter assembly for the returned sample to evaluate for potential valve functionality issues, the complaint cannot be confirmed as the result of a manufacturing nonconformance, and root cause is unknown.

• Brand Name: JELCO VIAVALVE PUR WINGED CATHETER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM
• 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: 21965041
• Report Number: 3012307300-2025-05226
• Device Sequence Number: 8131176
• Product Code: FOZ
• UDI-Device Identifier: 10351688081964
• UDI-Public: (01)10351688081964(17)270203(10)6091019
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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: Health Professional
• Device Catalogue Number: 328000
• Device Lot Number: 6091019
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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