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

Catalog Number	5-10315
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	01/09/2025
Type of Reportable Event	Serious Injury
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 "blown / deflated cuff during patient use".Additional information received states that there was no patient harm or injury, "just delay in care".However, the information states in regard to desaturation, "i am sure they did, all patients [desaturate] during this procedure".It is unknown what oxygen percentage the patient desaturated to.The issue was resolved by reintubating the patient.The current patient status is reported as "fine".

• Brand Name: ET TUBE, HVT, 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 21274419
• Report Number: 3003898360-2025-00105
• Device Sequence Number: 15471438
• Product Code: BTR
• UDI-Device Identifier: 04026704397044
• UDI-Public: (01)04026704397044(11)240614(17)290613(10)73F2400531(21)
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2025

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: 5-10315
• Device Lot Number: 73F2400531
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2024
• 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.
• Patient Sex: Unknown