MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE, HVT, 8.0; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-10316
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypoxia (1918); Insufficient Information (4580)
Date of Event	04/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one unit 5-10316 et tube,hvt,8.0 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 and 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 device was submerged underwater in order to test for leaks.Upon inflation , the device leaked from the balloon cuff.Multiple holes were found in a line on the balloon cuff.It appeared that the cuff was cut by something sharp.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 a 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." the reported complaint was confirmed based upon the sample received.The returned et tube was found to have multiple holes in a line in the balloon cuff which prevented it from being able to stay inflated.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.
Event or Problem Description
It was reported that: "pilot balloon ett failure.Initial failure may be related to agitation and possibly patient biting tube." associated complaints 3003898360-2024-00494, 3003898360-2024-00493 and 3003898360-2024-00495.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one unit 5-10316 et tube,hvt,8.0 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 and 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 device was submerged underwater in order to test for leaks.Upon inflation , the device leaked from the balloon cuff.Multiple holes were found in a line on the balloon cuff.It appeared that the cuff was cut by something sharp.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 a 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." the reported complaint was confirmed based upon the sample received.The returned et tube was found to have multiple holes in a line in the balloon cuff which prevented it from being able to stay inflated.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.Corrected data: uppdate to imdrf codes and incident description.
Event or Problem Description
It was reported that: "pilot balloon ett failure.Initial failure may be related to agitation and possibly patient biting tube.Patient was hypoxemic and not getting appropriate volumes.Required prolonged bagging." associated complaints 3003898360-2024-00494, 3003898360-2024-00496, 3003898360-2024-00493 and 3003898360-2024-00495.

• Brand Name: ET TUBE, HVT, 8.0
• 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: 19357707
• Report Number: 3003898360-2024-00496
• Device Sequence Number: 12366008
• Product Code: BTR
• UDI-Device Identifier: 04026704397051
• UDI-Public: 04026704397051
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 04/25/2024

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
• Device Catalogue Number: 5-10316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 05/21/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown