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

Catalog Number	326010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Event or Problem Description
It was reported that during iv removal in the post-anesthesia care unit; a portion of the plastic iv catheter broke off and remained in the patient.The patient was referred to the emergency department for evaluation, where imaging did not identify a retained foreign object, and was subsequently referred to a vascular surgeon for further assessment.There was patient involvement and reported harm.
Additional Manufacturer Narrative
D8: updated.H1, h3 and h6 codes: updated.Two photo samples were received, but no physical sample was returned for evaluation.The lot history was reviewed, and no nonconformities were identified that could have contributed to the reported complaint.Visual inspection of the submitted images showed one catheter tube severed approximately one-third of the length from the bevel tip.The photos are consistent with the complaint description.However, due to the resolution of the images, the root cause could not be determined.

• Brand Name: JELCO VIAVALVE SAFETY IV CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• 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: 25272360
• Report Number: 3012307300-2026-05334
• Device Sequence Number: 15795040
• Product Code: FOZ
• UDI-Device Identifier: 15019517078398
• UDI-Public: (01)15019517078398(17)270506(10)6120257
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2026

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: 326010
• Device Lot Number: 6120257
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 05/25/2026
• Supplement Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2025
• 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; Hospitalization
• Patient Sex: Unknown