MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE, CUFFED, SPIRAL-FLEX 7.5; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-12615
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the doctor found cuff leakage prior to use on patient then changed new one, no impact on patient".The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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 or Problem Description
It was reported that "the doctor found cuff leakage prior to use on patient then changed new one, no impact on patient".The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported complaint of "leak - device leak - cuff" could not be confirmed based upon the sample received.The customer returned one unit 5-12615 et tube, cuffed, spiral-flex 7.5 for investigation.The returned et tube was visually examined with and without 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.A device history record review was performed, and no relevant findings were identified.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.Other remarks: n/a.Corrected data: n/a.

• Brand Name: ET TUBE, CUFFED, SPIRAL-FLEX 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17690899
• Report Number: 3003898360-2023-01281
• Device Sequence Number: 6531704
• Product Code: BTR
• UDI-Device Identifier: 04026704397419
• UDI-Public: 04026704397419
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K844296
• Number of Events Summarized: 1
• Summary Report (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): 08/18/2023

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 Catalogue Number: 5-12615
• Device Lot Number: 73C2300740
• 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: 08/18/2023
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2023
• 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