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	03/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The actual sample was not returned; however, the customer provided a photograph for evaluation.A visual exam was performed on the photograph and the failure mode was unable to be confirmed.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
Reported issue: the doctor found cuff leakage when using it on the patient.The device was replaced with a new one.There was no patient impact.
Event or Problem Description
Reported issue: the doctor found cuff leakage when using it on the patient.The device was replaced with a new one.There was no patient impact.
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 and two suction catheters were returned.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 tracheal (white) pilot balloon.Upon injection of air, both the tracheal balloon cuff and pilot balloon were able to properly inflate.Next, the syringe was refilled with air and connected to the valve of the bronchial (blue) pilot balloon.Upon injection of air, the bronchial balloon cuff and pilot balloon were initially able to inflate but started to slowly deflate.There appeared to be a small leak.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, a leak was detected in the notch of the tube where the bronchial inflation line enters the tube.The hole in the notch was caused by an incorrect insertion of the pin that creates the notch during manufacturing.A device history record review was performed and no relevant findings were identified.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." "cuff pressure should be monitored routinely to assure that an adequate seal is maintained and that the cuffs have not become overinflated." "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 was confirmed based upon the sample received.Upon functional inspection, a leak was detected in the notch of the tube where the bronchial inflation line enters the tube.The hole in the notch was caused by an incorrect insertion of the pin that creates the notch during manufacturing.A non-conformance was previously opened to further investigate this complaint issue by the manufacturing site.Corrective actions were implemented on 18 april 2023 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 16637921
• Report Number: 3003898360-2023-00520
• Device Sequence Number: 6465099
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023

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: 73D2200123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 05/03/2023
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown