MAUDE Adverse Event Report: ICU MEDICAL, INC. PORTEX TRACHEAL TUBE; TRACHEAL (W/WO CONNECTOR)

Catalog Number	101/815/080
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cuff leaked after placement.One report showed high cuff pressure.The tracheostomy cuff balloon burst, so an emergency exchange was done using a distal xlt #6 shiley after the procedure.The event happened in the hospital and was handled by a healthcare professional.Medical intervention was needed, including a trach exchange and a follow-up chest x-ray.There was no death or 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
H2) device evaluation: d3 manufacturer establishment name updated.H3, h6: no product was returned.The reported complaint could not be confirmed.If the product is returned this complaint will be reopened for further investigation.

• Brand Name: PORTEX TRACHEAL TUBE
• Common Device Name: TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): ICU MEDICAL, INC.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22341355
• Report Number: 3012307300-2025-07752
• Device Sequence Number: 9060897
• Product Code: BTO
• UDI-Device Identifier: 15019517077360
• UDI-Public: (01)15019517077360
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 101/815/080
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 07/22/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Unknown
• Patient Ethnicity: Hispanic