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

Model Number	IPN048896
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).A device history record review was performed and no relevant findings were identified.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
Reported issue: the tube passed the pre-test, but air leaking alarm occurred after intubation.
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.Functional inspection was performed to attempt to inflate and deflate the balloon cuffs on the returned et tube.A lab inventory syringe was filled with air and was connected to the valve of the pilot balloon.Using hand pressure, air was injected through the valve.Upon injection of air, the balloon cuff and pilot balloon were able to fully inflate but started to slowly deflate immediately.The sample was submerged underwater to test for leaks.Upon injection of air, the device leaked from the pilot balloon.There was a small hole in the pilot balloon which prevented the device from staying inflated.No other defects or anomalies were observed.A device history record review was performed and no relevant findings were identified.The ifu for this product states, "the cuff inflation system (cuffs , pilot balloons, valves) should be checked by inflation and deflation prior to use.If cuff is damaged, the tube should not be used." "care should be taken to avoid damaging the cuffs during intubation.If any one of the cuffs is damaged, the tube should not be used." the ifu also states , "deflate all cuffs prior to repositioning the tube.Movement of the tube with cuffs inflated could result in patient injury or in damage to the cuffs, requiring a tube change.Verify the position of the tube after each repositioning.".The reported complaint was confirmed based upon the sample received.The returned et tube was found to have a hole in the pilot balloon 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.
Event or Problem Description
Reported issue: the tube passed the pre-test, but air leaking alarm occurred after intubation.A new device was used without issue.The condition of the patient is reported as "fine".

• 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 ; 9194332672
• MDR Report Key: 16616167
• Report Number: 3003898360-2023-00409
• Device Sequence Number: 20047366
• Product Code: BTR
• UDI-Device Identifier: 14026704616753
• UDI-Public: 14026704616753
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2023

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: 09/15/2025
• Device Model Number: IPN048896
• Device Catalogue Number: 5-10315
• Device Lot Number: 73J2000450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2020
• 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