MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. ET TUBE HOLDER, STANDARD, W/BITE BLOCK; DEVICE,FIXATION,TRACHEAL TUBE

Catalog Number	81802
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "this product is not securing endotracheal tubes effective, and recently a patient coughed and self-extubated themselves.Two additional patients were found to have their endotracheal tubes 4-6cm higher than originally secured.Rrt verified that the tube holders were being used correctly; however, the tubes still migrated.After changing the securement device, it was noted it was no longer sticking on the cheek pads nor the straps around the tube".At the time of this report, the customer has not returned our requests for additional information.
Additional Manufacturer Narrative
Qn#(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis a device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "this product is not securing endotracheal tubes effective, and recently a patient coughed and self-extubated themselves.Two additional patients were found to have their endotracheal tubes 4-6cm higher than originally secured.Rrt verified that the tube holders were being used correctly; however, the tubes still migrated.After changing the securement device, it was noted it was no longer sticking on the cheek pads nor the straps around the tube".At the time of this report, the customer has not returned our requests for additional information.

• Brand Name: ET TUBE HOLDER, STANDARD, W/BITE BLOCK
• Common Device Name: DEVICE,FIXATION,TRACHEAL TUBE
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21413680
• Report Number: 8040412-2025-00057
• Device Sequence Number: 12823179
• Product Code: CBH
• UDI-Device Identifier: 14026704646972
• UDI-Public: (01)14026704646972(11)240502(17)260430(10)40Z24E0074(21)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

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: Health Professional
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: 81802
• Device Lot Number: 40Z24E0074
• 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: 01/28/2025
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2024
• 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: N/A.; N/A.
• Patient Sex: Unknown