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

Catalog Number	V5-10115
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that during "a code we had multiple 7.5 etts fail to seal after intubation.4 ett failed after placement in the patient, but passed a leak test before intubation.One ett after being removed from the patient had the cuff leak saline after trying to check the integrity of the cuff balloon." the report also states, the patient had a large neck, tongue, and a larger than normal trach that may have intensified the situation.Patient didn't desaturate.Each at the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.See associated mdrs #3003898360-2023-01183, 3003898360-2023-01184, 3003898360-2023-01185.
Event or Problem Description
It was reported that during "a code we had multiple 7.5 etts fail to seal after intubation.4 ett failed after placement in the patient, but passed a leak test before intubation.One ett after being removed from the patient had the cuff leak saline after trying to check the integrity of the cuff balloon." the report also states, the patient had a large neck, tongue, and a larger than normal trach that may have intensified the situation.Patient didn't desaturate.Each at the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.See associated mdrs #3003898360-2023-01183, 3003898360-2023-01184, 3003898360-2023-01185.
Additional Manufacturer Narrative
(b)(4).Additional information received on 10 august 2023 states that there was no patient harm or injury.The current status of the patient is "unknown".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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.Other remarks: n/a.Corrected data: n/a.

• Brand Name: ET TUBE,CF,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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17436591
• Report Number: 3003898360-2023-01213
• Device Sequence Number: 6742279
• Product Code: BTR
• UDI-Device Identifier: 04026704588756
• UDI-Public: 04026704588756
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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,Followup
• Report Date (Section B): 07/17/2023

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: V5-10115
• Device Lot Number: 73B2300455
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/18/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2023
• 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: N/A.; N/A.
• Patient Sex: Unknown