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

Catalog Number	100/179/070
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4 - expiration date and h4 - device mfr date are unknown.No information is available based on the reported lot number.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 upon admission to the icu, the patient was experiencing rapid spontaneous breathing and low blood oxygen saturation, with indications for tracheal intubation.The doctor immediately performed bedside tracheal intubation and connected the patient to a ventilator for assisted breathing.The patient's respiratory alarm indicated a low tidal volume.The doctor checked the patient's vital signs, which were stable, and noted that the breathing was smooth.There was a significant difference between the inhaled tidal volume and the exhaled tidal volume.After the bag was inflated, it quickly deflated, suggesting an air leak in the bag.Therefore, the tracheal tube was replaced.

• Brand Name: PORTEX ENDOTRACHEAL TUBES
• 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: 25150744
• Report Number: 3012307300-2026-04868
• Device Sequence Number: 9397301
• Product Code: BTR
• UDI-Device Identifier: 15019315022128
• UDI-Public: (01)15019315022128
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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: 100/179/070
• Device Lot Number: 6006062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/12/2026
• 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 Age: 85 YR
• Patient Sex: Male