MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE, SHER-I-BRONCH, LS, 35 FR; TUBE, TRACHEAL/BRONCHIAL, DIFF

Model Number	IPN048995
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
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".No patient involvement.
Additional Manufacturer Narrative
(b)(4).The reported complaint of "leak - balloon cuff" was confirmed based upon the sample received.The customer returned one unit 5-16035 et tube, sher-i-bronch, ls, 35 fr for investigation.The et tube was returned out of its original packaging.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 cuffs on the returned et tube.A lab inventory syringe filled with air was connected to the valve of the bronchial (blue) pilot balloon.Upon injection of air, both the bronchial balloon cuff and pilot balloon were able to properly inflate.Next, the syringe was refilled with air and connected to the valve of the tracheal (white) pilot balloon.Upon injection of air, the tracheal pilot balloon was able to properly inflate.However, the tracheal balloon cuff did not inflate at all.The inflation line appeared to be blocked.After successfully deflating the cuffs and pilot balloons, the et tube was submerged underwater to detect any leaks.Upon injection of air into both inflation lines, no leaks were detected.Next, water was injected into the tracheal 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 tracheal 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.Additionally, the ifu for this product, was reviewed as a part of this complaint investigation.The ifu also 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." "cuff pressure should be monitored routinely to assure that an adequate seal is maintained and that the cuffs have not become over-inflated." "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." a device history record review was performed with no evidence to suggest a manufacturing related cause.Corrective actions were implemented under teleflex's quality system to help prevent this issue from recurring and the returned sample was manufactured prior to these corrective actions.
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".No patient involvement.

• Brand Name: ET TUBE, SHER-I-BRONCH, LS, 35 FR
• Common Device Name: TUBE, TRACHEAL/BRONCHIAL, DIFF
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17098549
• Report Number: 3003898360-2023-00915
• Device Sequence Number: 16627264
• Product Code: CBI
• UDI-Device Identifier: 14026704617392
• UDI-Public: 14026704617392
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K180253
• 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): 05/22/2023

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 Model Number: IPN048995
• Device Catalogue Number: 5-16035
• Device Lot Number: 73F2200323
• 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: 05/22/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2022
• 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