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 Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); Foreign Body In Patient (2687)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a plastic iv catheter broke off inside the patient¿s vein during infusion.The needle was new and within its expiration date.Ems personnel were informed upon arrival that the iv site was leaking and suspected the cannula had been problematic.Attempts to stop the leak and assess the iv showed blood return and leakage, but no infiltration or blown vein.When the line was removed, the catheter was missing and could not be retrieved due to blood obstructing visibility.The patient was transported to corvallis hospital for medical intervention, including surgical removal of the catheter.The incident occurred while the patient was stationary on the cot in a non-moving ambulance.The patient¿s care was disrupted, medical intervention was required, and the incident posed a safety threat.No follow-up information on the outcome or reported harm is available.
Additional Manufacturer Narrative
H3: the actual device was not received; however, two photos of the device were received for evaluation.A review of the lot history identified no discrepancies or abnormalities relevant to the complaint.The photos were visually examined for potential nonconformances, noting catheter tube severance; however, the probable cause could not be determined due to limited resolution and the device not being available for direct inspection.Per the instructions for use, improper handling of the catheter or introducer needle can result in severance, and no evidence of a manufacturing nonconformance was identified.Complaint information will continue to be monitored, with corrective actions implemented as necessary based on post-market trend analysis.
Additional Manufacturer Narrative
D9 - date returned to mfr - 6/1/2026.Complainant returned 61 unused/unopened sister samples, as well as two photos, for analysis.However, the probable cause was indeterminate based on the limited resolution.Review of manufacturing logbooks identified no definitive root cause for the alleged complaint.Sister samples were randomly sampled and tested per product specification requirements.All evaluated samples were found to be acceptable without failure.Without the actual device available for investigation, the complaint cannot be confirmed as a manufacturing nonconformance.

• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24507637
• Report Number: 3012307300-2026-02020
• Device Sequence Number: 13376078
• Product Code: FOZ
• Combination Product (Y/N): N
• 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): 07/16/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 326610
• Device Lot Number: 6129963
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown