MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE,CF,7.5; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-10115
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "31 march 2026, during use, the tube body and tube connector detached.".
Additional Manufacturer Narrative
(b)(4).It was reported that"31 march 2026, during use, the tube body and tube connector are detached.Inspection of the video confirmed the defect reported by the customer "detached connector".A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.A verification of failure mode reported in the current manufacturing process was conducted as follows: 25 samples were taken from the current production; the samples were dimensionally inspected, and issue reported "detached connector" was not observed in the current manufacturing process.A device history record (dhr) review was conducted for relevant materials and batches.No nonconformances or manufacturing-related i ssues were identified that could be associated with the reported condition.Failure mode "detached connector" could be confirmed with video returned.However it is necessary to receive the physical sample to perform a proper investigation, determine the root cause & corrective actions.If the complaint samples become available at a later date, this complaint will be updated accordingly.

• Brand Name: ET TUBE,CF,7.5
• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24966073
• Report Number: 3003898360-2026-00199
• Device Sequence Number: 20072245
• Product Code: BTR
• UDI-Device Identifier: 04026704396818
• UDI-Public: (01)04026704396818(11)241105(17)291104(10)73K2401068(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: 5-10115
• Device Lot Number: 73K2401068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED
• Patient Sex: Unknown