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

Model Number	IPN048895
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "during a virtual in-service this morning, [it was mentioned] that one of the sheridan tubes [being used] on a patient was losing air.Additionally, it was mentioned that "it had been used on the patient for 2 days".Patient condition unknown at time of report.Multiple attempts for additional information to the customer has been unsuccessful.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A verification of failure mode reported in the current manufacturing process was conducted as follows: 325 samples were taken from the current production (p/n 00003-14 l/n 3172684), 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 "leak - info not provided" was not observed in the current manufacturing process.A device history record review could not be conducted since the lot number of the device 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 5-10315 et tube, hvt, 7.5 for investigation.The et tube was visually examined with and without magnification.Visual examination of the returned device revealed that the sample appears typical.No defects or anomalies were observed.The returned sample was reviewed with a r & d engineer.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 stay inflated.The et tube was submerged under water and an attempt to inflate was made to detect any additional leaks.Upon injection, the et tube leaked from a hole in the balloon cuff.No other defects or anomalies were observed.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 a hole 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: section d.1.-brand name corrected to hudson et tube, hvt, 7.5 section d.4.-catalog# corrected to 5-10315.
Event or Problem Description
It was reported "during a virtual in-service this morning, [it was mentioned] that one of the sheridan tubes [being used] on a patient was losing air.Additionally, it was mentioned that "it had been used on the patient for 2 days".Patient condition unknown at time of report.Multiple attempts for additional information to the customer has been unsuccessful.

• Brand Name: HUDSON ET TUBE, HVT, 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: 13061596
• Report Number: 3003898360-2021-01098
• Device Sequence Number: 16559415
• Product Code: BTR
• UDI-Device Identifier: 14026704616746
• UDI-Public: 14026704616746
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2021

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
• Device Model Number: IPN048895
• Device Catalogue Number: 5-10315
• Device Lot Number: UNSURE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 01/26/2022
• 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