MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ET TUBE,CF,4.0; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN048866
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cuff did not inflate during a pretest before use.Therefore, a new unit was opened instead.It was reported no patient involvement.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Part number reported is not being manufactured currently, however, another part number from the same family was used for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: 90 samples were taken from the current production, the cuff from the samples were inflated and left for four hours, after this time samples were checked to verify if any leak was present however all samples were still fully inflated, defect reported "unable to inflate - cuff" was not observed in the current manufacturing process.A device history record review could not be conducted since the lot number was not provided.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.
Additional Manufacturer Narrative
(b)(4).The customer returned one unit 5-10108 et tube, cf, 4.0 for investigation.The et tube was visually examined with and without magnification.Visual examination of the returned device revealed that it appears typical.Functional inspection was performed to attempt to inflate and deflate the cuff on the returned et tube.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.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.The 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.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 that the cuff did not inflate during a pretest before use.Therefore, a new unit was opened instead.It was reported no patient involvement.

• Brand Name: HUDSON ET TUBE,CF,4.0
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 14631475
• Report Number: 3003898360-2022-00180
• Device Sequence Number: 3638737
• Product Code: BTR
• UDI-Device Identifier: 14026704616456
• UDI-Public: 14026704616456
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2022

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 Expiration Date: 08/02/2026
• Device Model Number: IPN048866
• Device Catalogue Number: 5-10108
• Device Lot Number: 73H2100146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2021
• 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