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

Catalog Number	5-10315
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: patient was being intubated for endoscopy procedure.Crna tested ett cuff prior to intubation.Patient was int ubated without incident using rsi by crna with rn support.Crna noted difficulty keeping cuff inflated.Patient with stable vital signs throughout.Orogastric tube placed temporarily per dr verbal order to decompress stomach to see if issue resolved.50ml gastric contents suctioned out and og tube removed.Ett cuff still not inflating correctly.Decision made by anesthesiologist and crna to remove ett and reintubate with a new tube.Patient then intubated without difficulty and cuff inflated by crna.Defective ett was tested in a graduated cylinder of water, and an air leak was noted at the seal of the cuff to the tube.Tube discarded after defect was shown to endo charge rn and endoscopy manager.
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.

• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19219304
• Report Number: 3003898360-2024-00415
• Device Sequence Number: 8241604
• Product Code: BTR
• UDI-Device Identifier: 04026704397044
• UDI-Public: 04026704397044
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/02/2024

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: 5-10315
• Device Lot Number: 73F2300747
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2023
• 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
• Patient Sex: Unknown