MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE, CUFFED, SPIRAL-FLEX 7.5; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-12615
Medical Device Problem Codes	Material Perforation (2205); Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "leakage was noted due to perforation.Changed to another device.There was no reported patient harm or injury." associated complaints: 3003898360-2024-01488, 3003898360-2024-01502, 3003898360-2024-01501, 3003898360-2024-01500 and 3003898360-2024-01486.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Failure mode "leak - device leak - other" could be confirmed with video provided.However, it is necessary to receive the physical sample to perform a proper investigation, determinate the root cause & corrective actions.Device history review investigation did not show issues related to complaint.If the complaint samples become available at a later date, this complaint will be updated accordingly.
Event or Problem Description
It was reported that: "leakage was noted due to perforation.Changed to another device.There was no reported patient harm or injury." associated complaints: 3003898360-2024-01488, 3003898360-2024-01502, 3003898360-2024-01501, 3003898360-2024-01500 and 3003898360-2024-01486.

• Brand Name: ET TUBE, CUFFED, SPIRAL-FLEX 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20770452
• Report Number: 3003898360-2024-01488
• Device Sequence Number: 18121199
• Product Code: BTR
• UDI-Device Identifier: 04026704397419
• UDI-Public: (01)04026704397419(11)230310(17)280309(10)73C2300323(21)
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K844296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

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: 5-12615
• Device Lot Number: 73C2300323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2023
• 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; NOT REPORTED
• Patient Sex: Unknown