MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE,CF,6.0; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-10112
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "the customer is reporting the cuff is leaking (not holding air)".Prior to use on patient.
Additional Manufacturer Narrative
(b)(4).The reported complaint of "leak - cuff" was confirmed based upon the investigation of the sample received.The customer returned one unit 5-10112 et tube, cf, 6.0 for investigation.Although no defects or anomalies were observed with the cuff, the returned et tube was found to have a hole in the pilot balloon which prevented both the pilot balloon and cuff from staying fully inflated.A device history record review was performed with no evidence to suggest a manufacturing related cause.All et tubes are 100% inspected for inflation and deflation at manufacturing by inflating the cuffs and allowing them to remain inflated for four hours prior to being deflated.It is unlikely that this type of damage was present at the time of manufacturing.Therefore, based upon the damage observed, unintentional user error caused or contributed to this event.
Event or Problem Description
It was reported that: "the customer is reporting the cuff is leaking (not holding air)".Prior to use on patient.

• Brand Name: ET TUBE,CF,6.0
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24546441
• Report Number: 3003898360-2026-00112
• Device Sequence Number: 5597252
• Product Code: BTR
• UDI-Device Identifier: 04026704396788
• UDI-Public: (01)04026704396788(11)271010(17)271010(10)73K2200402(21)
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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: 5-10112
• Device Lot Number: 73K2200402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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