MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V TRACHEAL TUBE IVORY; BASIC ENDOTRACHEAL TUBE, SINGLE USE

Catalog Number	100/179/080
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that leakage from the cuff was observed several times approximately 2 hours after intubation.The tube in the patient was changed as a result of the leakage.The same health care professionals did all the procedures, and the inflation of the cuff was done as always.There was patient involvement, and no patient harm/adverse event occurred.
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.
Additional Manufacturer Narrative
D2b - procode - corrected.
Additional Manufacturer Narrative
H3: two used samples were returned for analysis.Visual inspection found no damage.Functional testing was performed where the returned used cuff was inflated using an icu medical provided syringe.There were no leaks or difficulties observed during inflation.Additionally, the two (2) new samples were inflated and leak tested and no leaks were observed.The customer issue of cuff leakage could not be confirmed nor replicated.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: TRACHEAL TUBE IVORY
• Common Device Name: BASIC ENDOTRACHEAL TUBE, SINGLE USE
• 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: 23704892
• Report Number: 3012307300-2025-13119
• Device Sequence Number: 16100859
• Product Code: BTR
• UDI-Device Identifier: 15019315022142
• UDI-Public: (01)15019315022142(17)291108(10)6060147
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2026

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: 100/179/080
• Device Lot Number: 6060147
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 11/12/2025; 03/18/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 03/04/2026; 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2024
• 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