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

Model Number IPN044731

Device Problem Deflation Problem (1149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/27/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A verification of failure mode reported in the current manufacturing process was conducted as follows: 200 samples were taken from the current production; the samples were visually inspected and issue reported "deflates slowly - cuff" was not observed in the current manufacturing process.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 Description

It was reported that "on the (b)(6) 2021, the anaesthesists observed that the cuff of the et tube deflates.It is impossible to maintain a constant volume and when checking with the manometer it showed a decrease in pressure.Clinical consequences: the et tube was replaced without any consequences for the patient".No patient injury or harm reported.Patient condition reported as "fine".

Event Description

It was reported that "on (b)(6) 2021, the anaesthesists observed that the cuff of the et tube deflates.It is impossible to maintain a constant volume and when checking with the manometer it showed a decrease in pressure.Clinical consequences: the et tube was replaced without any consequences for the patient".No patient injury or harm reported.Patient condition reported as "fine".

Manufacturer Narrative

Qn# (b)(4).The customer returned one unit 5-10115 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 appears typical.No defects or anomalies were observed.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 as it would slowly deflate.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 small 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 of "deflates slowly - cuff" 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.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.

• Brand Name: HUDSON ET TUBE,CF,7.5
• Type of Device: TUBE, TRACHEAL (W/WO CONNECTOR
• MDR Report Key: 12373209
• MDR Text Key: 268326160
• Report Number: 3003898360-2021-00750
• Device Sequence Number: 1
• Product Code: BTR
• UDI-Device Identifier: 14026704616524
• UDI-Public: 14026704616524
• Combination Product (y/n): N
• PMA/PMN Number: K822082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/04/2021

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 Operator: Health Professional
• Device Expiration Date: 01/22/2024
• Device Model Number: IPN044731
• Device Catalogue Number: 5-10115
• Device Lot Number: 73A1900732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 09/17/2021
• Supplement Dates FDA Received: 09/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MANOMETER; MANOMETER; MANOMETER