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
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 #3003898360-2023-01184, 3003898360-2023-01185, 3003898360-2023-01213.
Additional Manufacturer Narrative
Qn#(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.
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 #3003898360-2023-01184, 3003898360-2023-01185, 3003898360-2023-01213.
Additional Manufacturer Narrative
Qn#(b)(4) the reported complaint of "leak - device leak - cuff" was confirmed based upon the sample received.The customer returned one-unit v5-10115 et tube, cf,7.5 for investigation.The et tube was visually examined with and without magnification.Visual examination of the returned device revealed that the sample appeared typical.No defects or anomalies were observed.Functional inspection was performed on the returned device to test for proper inflation/deflation.A lab inventory syringe was filled with air and attached to the pilot balloon.Upon injection of air, the balloon cuff was unable to stay inflated.The et tube was submerged under water to test for leaks.Upon injection of air, the et tube leaked from multiple holes in the balloon cuff.Upon further examination, the holes in the cuff were in a line.It appeared that something sharp scraped against the cuff as there is a visible line on the cuff where the holes were present.The ifu for this product states, "the tracheal tube cuff inflation system, including the valve, should be checked prior to intubation.If a malfunction is detected in any part of the system, the tube should not be used." "care should be taken to avoid damaging the thin-walled cuffs during intubation.If cuff is damaged, the tube should not be used." the ifu also states, "cuff pressure should be monitored routinely to assure that an adequate tracheal seal is maintained and that the cuff has not become over-inflated.The tracheal tube cuff should be slowly inflated with the minimum amount of air required to provide an effective tracheal seal.Do not inflate with a measured volume of air or by "feel" of pressure in the syringe since little resistance should be felt during inflation." a device history record review was performed with no evidence to suggest a manufacturing related cause.All et tubes are 100% inspected for inflation and deflation at the time of manufacturing.It is unlikely that this type of damage was present at the time of manufacturing.Therefore, based upon the damage observed, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend on complaints of this nature.******************* additional information received on (b)(6) 2023 stated that there was no patient harm or injury.The current status of the patient is "unknown".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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17440261
• Report Number: 3003898360-2023-01183
• Device Sequence Number: 11489398
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: V5-10115
• Device Lot Number: 73B2300455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/08/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown