MAUDE Adverse Event Report: ICU Medical, Inc. TD Torque-Line Catheter, 8F, 5 lumen, 110 cm, RA/RA, Heparin Coated; Catheter, oximeter, fiber-optic

Catalog Number	412370405
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a td torque-line catheter.It was reported that during placement of the thermodilution catheter, the syringe attached to the tubing was found cracked with a broken plunger.The was no reported patient involvement however, no patient harm or injury was reported.
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.

• Brand Name: TD Torque-Line Catheter, 8F, 5 lumen, 110 cm, RA/RA, Heparin Coated
• Common Device Name: Catheter, oximeter, fiber-optic
• Manufacturer (Section D): ICU Medical, Inc.; 4455 s. atherton drive; salt lake city UT 84123
• Manufacturer Contact: reed covert ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50867697
• Report Number: 1713468-2026-00010
• Device Sequence Number: 13106363
• Product Code: DQE
• UDI-Device Identifier: 00840619044039
• UDI-Public: (01)00840619044039(17)270901(10)14907455
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K091268
• 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): 09/23/2026

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: 412370405
• Device Lot Number: 14907455
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2026
• 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
• Patient Sex: Unknown