MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/110/070
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the product had a leakage, the cuff was punctured.There was no reported patient involvement or harm.
Additional Manufacturer Narrative
No product samples, pictures, or videos were received for evaluation.The complaint of a punctured cuff could not be confirmed by investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The lot history was reviewed; no relevant nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PORTEX
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23544991
• Report Number: 3012307300-2025-12452
• Device Sequence Number: 9531211
• Product Code: BTR
• UDI-Device Identifier: 15019315050787
• UDI-Public: (01)15019315050787(17)281001(10)4430802
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K032112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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: 100/110/070
• Device Lot Number: 4430802
• 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: 10/24/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2023
• 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