MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ET TUBE, CUFFED, SPIRAL-FLEX 7.0; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN044799
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Current part number is not being manufactured currently, however, another part number from the same family was use for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: 80 samples were taken from the current production from the assembly,spiral-flex nasal tube,8.0 mm the samples were visually inspected and issue reported "leak - device leak - 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.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 that: "following intubation of patient, it was noted that there was a leaky pilot cuff.Extra air was required several times during procedure, however procedure continued uneventfully and there was no issue for patient.' patient condition reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one unit 5-12614 et tube, cuffed, spiral-flex 7.0 for investigation.The et tube was visually examined with and without magnification.Visual examination of the returned device that the pilot balloon was detached from the inflation line.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 pilot balloon was detached from the inflation line which would prevent the cuff from being able to inflate.The customer reported that there was a leak from the pilot balloon.It is possible that the pilot balloon leaked during use and detached during shipping since there was no mention that the pilot balloon detached during use.The manufacturing site was consulted for this complaint issue.It was confirmed that the pilot balloon was properly adhered to the inflation line.It appears that the pilot balloon was pulled too hard which caused it to detach from the inflation line.The tip of the inflation line that the pilot balloon attaches to was slightly damaged which supports this root cause.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.Based on the condition of the sample received, it appears that unintentional user error caused or contributed to this event.
Event or Problem Description
It was reported that: "following intubation of patient, it was noted that there was a leaky pilot cuff.Extra air was required several times during procedure, however procedure continued uneventfully and there was no issue for patient.' patient condition reported as "fine".

• Brand Name: HUDSON ET TUBE, CUFFED, SPIRAL-FLEX 7.0
• 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 ; 9193614124
• MDR Report Key: 14435258
• Report Number: 3003898360-2022-00172
• Device Sequence Number: 17554164
• Product Code: BTR
• UDI-Device Identifier: 04026704397402
• UDI-Public: 04026704397402
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K844296
• 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): 05/04/2022

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: 10/21/2025
• Device Model Number: IPN044799
• Device Catalogue Number: 5-12614
• Device Lot Number: 73K2000503
• 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: 05/04/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2020
• 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