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

Model Number	IPN048960
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the doctor found cuff leakage when doing clinical setting before using on patient.Then changed new one.No impact on patient.".
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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 when doing clinical setting before using on patient.Then changed new one.No impact on patient.".
Additional Manufacturer Narrative
Qn#(b)(4).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 appeared typical.No defects or anomalies were observed.A functional inspection was performed to attempt to inflate and deflate the balloon cuff on the returned et tube.A lab inventory syringe filled with air was connected to the valve of the pilot balloon.Upon injection of air, the pilot balloon was able to properly inflate.However, the balloon cuff did not inflate at all.The inflation line appeared to be blocked.After deflating the pilot balloon, water was injected into the inflation line to identify where the blockage in the inflation line was.Upon injection of the water, no water got past the distal end of the pilot balloon.Therefore, there appears to be an obstruction in the inflation line at the distal end of the pilot balloon.The obstruction was caused by adhesive material getting into the distal end of the pilot balloon during assembly and blocking the inflation line.A device history record review was performed and no relevant findings were identified.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 detected in any part of the inflation system, the tube should not be used." the reported complaint was confirmed based upon the sample received.Upon functional inspection, the inflation line was found to be obstructed at the distal end of the pilot balloon which prevented the balloon cuff from inflating properly.The obstruction was caused by adhesive material getting into the distal end of the pilot balloon during assembly and blocking the inflation line.A non-conformance was previously opened to further investigate this complaint issue by the manufacturing site.Corrective actions were implemented in aug 2022 to help prevent this issue from recurring.The returned sample was manufactured prior to these corrective actions.

• Brand Name: HUDSON 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15606798
• Report Number: 3003898360-2022-00518
• Device Sequence Number: 19402500
• Product Code: BTR
• UDI-Device Identifier: 14026704617088
• UDI-Public: 14026704617088
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2022

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: 06/16/2025
• Device Model Number: IPN048960
• Device Catalogue Number: 5-12615
• Device Lot Number: 73F2000389
• 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: 09/23/2022
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2020
• 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