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

Catalog Number	328700
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	02/19/2025
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 iv was removed from the patient it slid the safety lock into place.The device seemed to extend past the lock and exposed the needle which eventually poked the operator of the device in the right thumb.There was unknown if exposure to hiv/hep b had happened given that the patient is a drug user.The operator of the device reported that they are pregnant and thus was not allowed to take prophylactic treatment.Serology was done with no further information provided.
Additional Manufacturer Narrative
Device history review could not be performed as lot number was unknown.No investigation or root cause analysis could be conducted given that no complaint sample was returned.As a result, the cause is unknown due to no product returned.If the device is returned, the complaint will be reopened for further investigation.

• Brand Name: VIAVALVE PUR WINGED SAFETY ACTIVE CATHETERS
• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21669498
• Report Number: 3012307300-2025-03174
• Device Sequence Number: 8228528
• Product Code: FOZ
• UDI-Device Identifier: 10351688081940
• UDI-Public: (01)10351688081940
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 328700
• Device Lot Number: UNKNOWN
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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