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

Catalog Number	328600
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was returned for investigation.The photo received shows a severed catheter that had been pulled from a patient, next to a good part to show the length of the catheter pulled from the patient is approximately the same as the device that had been used on the patient; thereby confirming the event.Without the return of the device a probable root cause is unable to be determined.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Per instructions for use (ifu), clinicians should avoid the use of scissors or sharp instruments near i.V.Catheters as it may result in cutting/severing the catheter tube.It is important to note that catheter severance can be attributed to practices not supported by the infusion nurses society standards of practice.These types of practices include, but are not limited to: reinsertion of the needle during initial iv placement.Placement of the iv in a joint of flexion where the catheter will be subject to repeated bending/kinking use of scissors to cut tape when removing an iv catheter may result in inadvertent cutting of the catheter.
Event or Problem Description
It was reported that patient had nausea and vomiting and had an intravenous (iv) put in for blood work and medications.The patient then presented with redness to the left hand where iv had been.Tenderness and pain to area.Upon inspection, there was a small area that was rollable and palpable cannula in hand.The physician cut into hand and pulled out a small 7cm tube.There was patient involvement, and no patient harm.

• 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25738724
• Report Number: 3012307300-2026-07129
• Device Sequence Number: 10283551
• Product Code: FOZ
• UDI-Device Identifier: 10351688081957
• UDI-Public: (01)10351688081957(17)280123(10)6181834
• 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
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/07/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 328600
• Device Lot Number: 6181834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2026
• 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