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

Catalog Number	5-10315
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the cuff leaked during use on patient." awaiting additional information.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).Several attempts were made to get additional information regarding the event; however, nothing was received at the time of this report.If additional information is received, another follow up report will be submitted.The customer returned one unit 5-10315 et tube, hvt, 7.5 for investigation.The returned et tube was visually examined with and with out magnification.Visual examination of the returned et tube revealed that the sample appears typical.A functional inspection was performed to attempt to inflate and deflate the balloon cuff on the returned et tube.A lab inventory syringe was filled with air and attached to the valve of the pilot balloon.Upon injection of air, both the pilot balloon and cuff immediately inflated.The syringe was then removed and the cuff and pilot balloon were inspected for leaks.No leaks were detected.The syringe was then reattached in order to deflate the balloons.Both the pilot balloon and balloon cuff were able to deflate.The et tube was submerged underwater and an attempt to inflate the balloon cuff was made in order to detect any leaks.Upon injection of air, no leaks were detected.No functional issues were found with the returned sample.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 pat ient injury or in damage to the cuffs, requiring a tube change.Verify the position of the tube after each repositioning." the reported complaint could not be confirmed based upon the sample received.The returned et tube was able to inflate and deflate with no difficulty.All et tubes are 100% inspected for both inflation and deflation at the time of manufacturing.No functional issues were found with the returned device.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that: "the cuff leaked during use on patient.".

• Brand Name: 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: 19219437
• Report Number: 3003898360-2024-00416
• Device Sequence Number: 8105982
• Product Code: BTR
• UDI-Device Identifier: 04026704397044
• UDI-Public: 04026704397044
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 04/02/2024

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 Catalogue Number: 5-10315
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 05/14/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown