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

Catalog Number	100/199/070
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 information becomes available.
Event or Problem Description
It was reported that the tubes cuff deflated whilst in a patient.The patient had to be extubated and then reintubated.The reported device was replaced with another one and no further problems encountered.There was reported patient involvement but no patient harm.
Additional Manufacturer Narrative
H3: the devices were received for evaluation.As received, no damage or anomalies were observed.The lot history was reviewed, and no relevant nonconformities were identified that may have contributed to the reported complaint.Visual and functional testing was performed to replicate clinical use, during which each tracheal tube cuff was inflated using an icu medical provided syringe and inflated as expected.To replicate the customer experience, the cuffs were left inflated for 24 hours, during which all cuffs remained inflated.The complaint of cuff deflation could not be replicated or confirmed.There was no known cause of the reported issue, and no further action will be taken.

• Brand Name: PORTEX TRACHEAL TUBE CLEAR MURPHEY EYESOFT SEAL
• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23838728
• Report Number: 3012307300-2025-13600
• Device Sequence Number: 9571958
• Product Code: BTR
• UDI-Device Identifier: 55019315022324
• UDI-Public: (01)55019315022324(17)300702(10)6125769
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (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): 01/26/2026

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: 100/199/070
• Device Lot Number: 6125769
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2025
• 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