MAUDE Adverse Event Report: ICU MEDICAL, INC. TD TORQUE-LINE CATHETER, 7F, 4 LUMEN, 110 CM, LF; CATHETER, OXIMETER, FIBER-OPTIC

Catalog Number	UNKNOWN
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an unspecified swan device generated a blood leak during patient use.The report states that "the anesthesiologist noticed a pool of blood on the floor in a spot that wouldn't usually have it.After about an hour into the case, the physician traced it to the thermistor connection port." there was no patient harm reported.
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Additional Manufacturer Narrative
No product samples, videos were returned for investigation.However, an image was provided by the customer showing stains of blood.A failure mode was not able to be identified from the image provided.Without the return of the reported sample, the complaint cannot be confirmed.A device history lot review could not be conducted because no lot number(s) was/were identified.

• Brand Name: TD TORQUE-LINE CATHETER, 7F, 4 LUMEN, 110 CM, LF
• Common Device Name: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 s. atherton drive; salt lake city UT
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20196661
• Report Number: 1713468-2024-00005
• Device Sequence Number: 6674771
• Product Code: DQE
• UDI-Device Identifier: 00840619043681
• UDI-Public: 00840619043681
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

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: 08/16/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 10/22/2024
• 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