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

Catalog Number	101/810/075
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
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 reportable information becomes available.
Event or Problem Description
It was reported that the cuff leaked after usage.The tracheostomy tube no.7.5 was found to be defective due to leakage in the balloon section.The tube was replaced with a tracheostomy tube no.7, which was functioning properly.The patient remained stable after the replacement procedure.The event occurred at hospital while in use with patient.The issue was resolved by changing to a new product.There was no patient harm/adverse event reported as a result of the event.
Additional Manufacturer Narrative
H3: one used sample was received for evaluation.Visual inspection was performed, and no damage or anomalies were observed.In attempts to replicate clinical use the bluselect tube was inflated using an icu medical provided syringe and it was observed that the cuff inflated however it deflated.The tube was reinflated and submerged in an underwater bath to visualize the location of the leak.The leak was observed to be coming from the cuff.Upon further inspection a cut was observed on the cuff.The cut was observed to have straight edges.The customer complaint of leakage was confirmed due to the cut observed.The probable cause of the cut is unknown.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: PORTEX TUBES BLUSELECT SUCTIONAID
• Common Device Name: TUBE, TRACHEOSTOMY (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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23353915
• Report Number: 3012307300-2025-11645
• Device Sequence Number: 9075980
• Product Code: BTO
• UDI-Device Identifier: 15019517077001
• UDI-Public: (01)15019517077001(17)291108(10)6058733
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K173384
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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: Other
• Device Catalogue Number: 101/810/075
• Device Lot Number: 6058733
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• 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 Age: 80 YR
• Patient Sex: Male