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

Catalog Number	100/199/065
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: month and year of event have been provided; day is unknown.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that there was a leak from the welded joint between the cuff and the upper tube.The event occurred during patient use, and there was no reported patient harm/adverse event.
Additional Manufacturer Narrative
One used sample was received for evaluation for the complaint that there was a leak from the welded joint between the cuff and the upper tube.The lot history was reviewed, and no relevant nonconformities were identified that may have contributed to the reported complaint.As received no damage or anomalies were observed.In attempts to replicate clinical use the tracheal tube was inflated using an icu medical provided syringe.It was observed that the cuff inflated however it deflated.The complaint of leakage can be confirmed.The probable cause is due to a welding error during manufacturing.

• Brand Name: PORTEX ENDOTRACHEAL TUBES, MURPHY EYE
• 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 ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23687069
• Report Number: 3012307300-2025-13013
• Device Sequence Number: 9365490
• Product Code: BTR
• UDI-Device Identifier: 15019315022319
• UDI-Public: (01)15019315022319(17)291128(10)6058723
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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: 100/199/065
• Device Lot Number: 6058723
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• 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