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

Catalog Number	5-16035
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported that "(b)(6) 2024, the doctor found cuff leakage when doing testing before using on patient.".
Event or Problem Description
It was reported that"(b)(6) 2024, the doctor found cuff leakage when doing testing before using on patient.".
Additional Manufacturer Narrative
(b)(4).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, only a very small amount of 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.Non-conformance was previously opened to further investigate this complaint issue by the manufacturing site.Corrective actions were implemented to help prevent this issue from recurring.The returned sample was manufactured prior to these corrective actions.Dhr investigation did not show issues related to complaint.The ifu 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." the reported complaint of "leak - balloon cuff" was confirmed based upon the sample received.Upon functional inspection, the tracheal (white) 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.Nonconformance was previously opened to further investigate this complaint issue by the manufacturing site.Corrective actions were implemented to help prevent this issue from recurring.The returned sample was manufactured prior to these corrective actions.

• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20809004
• Report Number: 3003898360-2024-01508
• Device Sequence Number: 21145901
• Product Code: CBI
• UDI-Device Identifier: 04026704397600
• UDI-Public: (01)04026704397600(11)220407(17)270406(10)73D2200123(21)
• 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): 11/11/2024

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: 5-16035
• Device Lot Number: 73D2200123
• 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: 11/11/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 11/29/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown