MAUDE Adverse Event Report: ICU MEDICAL, INC. TD CATHETER, 8F, 5 LUMEN, 110 CM, RA/RA, LF; CATHETER, OXIMETER, FIBER-OPTIC

Catalog Number	412170402
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.E1 initial reporter phone number:(b)(6).
Event or Problem Description
The event involved a td catheter, 8f, 5 lumen, 110 cm, ra/ra, lf where it was reported that the balloon ruptured when attempting to float the catheter.Floating the catheter of the device occurs inside the patient's body.There was patient involvement, however no harm reported.
Additional Manufacturer Narrative
The following was provided by the customer for investigation: -one used list# 412170402, td catheter, 8f, 5 lumen, 110 cm, ra/ra, lf; lot# 13955645 the reported complaint balloon rupture was confirmed on the returned device.During visual inspection, a tear was observed on the balloon of the td catheter.It is unknown how and when the tear had occurred on the balloon.The probable cause of the tear on the balloon is unknown.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: TD CATHETER, 8F, 5 LUMEN, 110 CM, RA/RA, LF
• 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 ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20912903
• Report Number: 1713468-2024-00009
• Device Sequence Number: 12878179
• Product Code: DQE
• UDI-Device Identifier: 00840619043599
• UDI-Public: (01)00840619043599(17)250401(10)13955645
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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 Expiration Date: 04/01/2025
• Device Catalogue Number: 412170402
• Device Lot Number: 13955645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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