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

Catalog Number	UNKNOWN
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned for analysis of complaint that physician incurred iv stick injury due to failed safety cover activation after use.Given no product has been provided and the investigation could not confirm whether a quality related issue has resulted in the customer reported problem, root cause could not be defined with confidence.All materials in the manufacturing process, as well as all finished good products are released to market based on approved quality specification.
Event or Problem Description
It was reported that physician incurred an iv stick injury due to failed safety cover activation after use.The physician was placing an iv in the patient¿s l external jugular.After receiving flash, they pulled back to retract the needle, however, the safety protector did not activate, and the physician incurred a needle stick injury.The event occurred at the hospital in emergency department.There was a patient involvement and there was no reported 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; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25184059
• Report Number: 3012307300-2026-05075
• Device Sequence Number: 13397624
• Product Code: FOZ
• UDI-Device Identifier: 15019517078428
• UDI-Public: (01)15019517078428
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2026

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: UNKNOWN
• 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: 04/23/2026
• Initial Report FDA Received Date: 05/15/2026
• 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