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

Catalog Number	326610
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one of their paramedics started a viavalve safety iv catheter 20g iv.They got good placement, but when they went to attached an extension to the catheter, the catheter detached at the pink hub.Leaving the flexible catheter inside the patient with no way to get it out.No significant delay, iv unable to be established when patient required one.Hospital had to remove the catheter that was left inserted in the patient.Iv was being started, no medication was being given.There was a patient involvement and there was a patient injury.
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
H3 and h6: updated.The suspected products were returned for evaluation.Visual inspection confirmed that there were no anomalies reported.The lot history review was performed, and it was confirmed that there were no previous conformities noted.The allegation made by the complainant could not be confirmed and the probable root cause of the event could not be identified.

• Brand Name: JELCO VIAVALVE SAFETY IV CATHETER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ICU 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: 24839361
• Report Number: 3012307300-2026-03577
• Device Sequence Number: 9594631
• Product Code: FOZ
• UDI-Device Identifier: 15019517078428
• UDI-Public: (01)15019517078428(17)271120(10)6164534
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

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: 326610
• Device Lot Number: 6164534
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/26/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2025
• 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 Age: 85 YR
• Patient Sex: Male
• Patient Weight: 50 KG
• Patient Race: White