MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE, HVT, 7.0; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-10314
Medical Device Problem Codes	Material Twisted/Bent (2981); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "during procedure, product kinked and was obstructed during surgery (too soft).The patient experianced high a irway pressures, brain herniation during neurosurgery.The saturations dropped below 95% for 5 minutes.".
Additional Manufacturer Narrative
Qn# (b)(4).Failure mode "occlusion kinked" could not be confirmed with picture attached.However it is necessary to receive the physical sample to perform a proper investigation, determinate the root cause & corrective actions.A device history record review was performed and no relevant findings were identified.If the complaint samples become available at a later date, this complaint will be updated accordingly.

• Brand Name: ET TUBE, HVT, 7.0
• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20810192
• Report Number: 3003898360-2024-01516
• Device Sequence Number: 15910484
• Product Code: BTR
• UDI-Device Identifier: 04026704397037
• UDI-Public: (01)04026704397037(11)240716(17)290715(10)73G2400446(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/26/2024

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: 5-10314
• Device Lot Number: 73G2400446
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 11/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2024
• 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