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

Model Number	IPN046759
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A verification of the reported failure mode was conducted, and 315 samples were taken from the current production (material number 00003-14 lot # 3024109) at the manufacturing facility.The samples were visually inspected, and issue reported "leak - device leak - cuff" was not observed.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.
Event or Problem Description
It was reported "crna lead ((b)(6) crna) reported 5 of the 7.5 ett's experiencing leaking cuffs when testing them prior to insertion into a patient".No patient involvement reported.It was reported that the device was replaced before use on patient.
Additional Manufacturer Narrative
Qn #(b)(4).The customer returned two units v5-10315 et tube, hvt, 7.5, nova plus for investigation.One sample was a representative sample and the other was the actual sample that caused the complaint.The et tubes were visually examined with and without magnification.Visual examination of the returned devices revealed that they both appear typical.Functional inspection was performed to attempt to inflate and deflate the cuff on the returned et tubes.The actual sample was tested first.A lab inventory syringe was filled with air.Then the syringe was connected to the pilot balloon.Using hand pressure, air was injected through the valve.Upon injection of air, the balloon cuff was unable to inflate.The et tube was submerged under water in order to detect any leaks.Upon injection, the et tube leaked from a hole in the inflation line where the inflation line enters the et tube.The inflation line had a small cut/hole which caused the leak.The representative sample was also tested.The representative sample was able to properly inflate and deflate with no issues.All et tubes are 100% inspected for inflation and deflation at manufacturing by inflating the cuffs and allowing them to remain inflated for four hours prior to being deflated.Therefore, it is unlikely that the hole in the inflation line was present at the time of manufacturing.It could not be determined how this defect occurred, but this appears to be an isolated event.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 reported complaint was confirmed based upon the sample received.Two samples were returned, one actual sample and one representative sample.The actual sample was found to have a hole in the inflation line where the inflation line enters the et tube which prevented the cuff from being able to inflate.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.The representative sample was able to function properly and no issues were observed with it.It could not be determined how this defect occurred, but this appears to be an isolated event.Teleflex will continue to monitor and trend on this issue.
Event or Problem Description
It was reported "crna lead (kari cole crna) reported 5 of the 7.5 ett's experiencing leaking cuffs when testing them prior to insertion into a patient".No patient involvement reported.It was reported that the device was replaced before use on patient.

• Brand Name: HUDSON ET TUBE,HVT,7.5,NOVA PLUS
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11667790
• Report Number: 3003898360-2021-00342
• Device Sequence Number: 2980544
• Product Code: BTR
• UDI-Device Identifier: 04026704588787
• UDI-Public: 04026704588787
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021

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 Expiration Date: 08/10/2025
• Device Model Number: IPN046759
• Device Catalogue Number: V5-10315
• Device Lot Number: 73H2000272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1