MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V TTS TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67HA70
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the first tracheostomy tube was placed and found leakage after 4 days of use.Then the second one was placed and found leakage on the 1st days of use.The event occurred while in use with patient at the hospital.There was no delay in therapy that was critical to this patient.This problem was solved by replacing with a new one.There was a patient involvement and there was unknown patient harm.
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
Two devices were received for evaluation.A lot history review was performed.The customer allegation was confirmed however, no manufacturing-related root cause was identified.Both devices were leaked tested, both devices appeared to leak in the same location.Using a verified ruler (copper sticker), the leak location on device one was approximately 10mm below the end of the inflation line and 3 mm towards the graduation printing on the shaft.Surrounding the point of leakage was abrasion marks approximately 2mm in diameter.Next to the abraded area surrounding the leak was another small, abraded area approximately 2.5 mm x 2mm.The leak location on device two was approximately 7mm below the end of the inflation line and 2 mm towards the graduation printing on the shaft.There were a few small, abraded marks visible, but significantly less than what was visible on device one.Prescence of abraded marks on the cuffs indicated that the devices encountered something sharp / rough.The lot passed both these inspections.Review of the process on the production floor did not identify anything that would have created the abraded marks.Due to the similar locations, it is likely that the devices came in contact with something sharp / rough either prior to intubation or during.

• Brand Name: TTS TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• 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: 24791514
• Report Number: 3012307300-2026-03322
• Device Sequence Number: 8859302
• Product Code: JOH
• UDI-Device Identifier: 15021312013801
• UDI-Public: (01)15021312013801(17)300228(10)6085358
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K081440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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: 67HA70
• Device Lot Number: 6085358
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/25/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2025
• 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