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

Catalog Number	328700
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device leak badly, causing a blood mess when inserting the iv (intravenous).There were delays in therapy or treatment.There was patient involvement, and no patient harm was reported.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable root cause is unable to be determined.Device history record was reviewed and no discrepancies or abnormalities relevant to the complaint were identified.Per instructions for use (ifu), section 4.2 warnings states the introducer needle must not be reinserted inside the catheter once the needle has been partially or completely withdrawn as it may pierce the catheter.Premature removal of the introducer needle from the catheter can result in catheter shear upon insertion as reported by the complainant.The catheter is thin wall by design & needs the needle in order to thread properly into the vessel, with the needle acting as a guide wire during the process.Per instructions for use (ifu), section 7.2 states the clinician shall remove sheath in straight outward motion and inspect device and ensure the catheter hub and primary push-off tab are fully seated to the ribbed housing assembly prior to insertion.Failure to ensure the catheter hub is fully seated prior to use, can result in catheter high trim (over the heel), difficulty to insert, and dull needles as reported by the complainant.

• Brand Name: VIAVALVE PUR WINGED SAFETY ACTIVE CATHETERS
• 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: 24628257
• Report Number: 3012307300-2026-02660
• Device Sequence Number: 21045995
• Product Code: FOZ
• UDI-Device Identifier: 10351688081940
• UDI-Public: (01)10351688081940(17)271009(10)6158288
• 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,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2026

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: Health Professional
• Device Catalogue Number: 328700
• Device Lot Number: 6158288
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2025
• 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