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

Catalog Number	412330402
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received regarding td catheter, 8f, 5 lumen, 110 cm, ra/ra, heparin coated, lf that experienced balloon rupture.It was stated in the report that the pa catheter balloon ruptured while in the patient.The sample is available for evaluation.The event occurred on (b)(6) 2025 during use.There was patient involvement, and no adverse event reported.
Additional Manufacturer Narrative
D4 and h4 the lot#, expiration date, and manufacture date are unknown.The investigation is pending completion.Upon completion of the investigation a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Investigation summary: the reported complaint of tear on the balloon was confirmed.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.A device history record lot# review could not be conducted because no lot number(s) was/were identified.

• Brand Name: TD CATHETER, 8F, 5 LUMEN, 110 CM, RA/RA, HEPARIN COATED, 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: 21673026
• Report Number: 1713468-2025-00004
• Device Sequence Number: 8175507
• Product Code: DQE
• UDI-Device Identifier: 00840619043735
• UDI-Public: 00840619043735
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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 Catalogue Number: 412330402
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 03/22/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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