MAUDE Adverse Event Report: TELEFLEX MEDICAL DOUBLE LUMEN BRONC. TUBE SET CARINA H.; TUBE, BRONCHIAL (W/WO CONNECT

Model Number	IPN047059
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	05/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a thoracic surgery, the bronchial cuff deflated, even after re-inflating the cuff.The cuff had been pretested prior to a successful intubation for a thoracic surgery.After the deflation was discovered during surgery, continuous monitoring of the cuff pressure was performed and regular re-inflation was performed to maintain pressure of the cuff.As a result, "there was poor ventilation of the patient during the procedure due to the lack of sealing of the cuff".Additional information received states that the "patient faced occasional and recurrent desaturations related to ventilatory difficulties.However, no other major clinical consequence for the patient".There was no information provided on the oxygen saturation percentages that the patient experienced.The current status of the patient is reported as "post-operative follow up without anything special for the current condition".
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
(b)(4).Complaint verification testing was performed as the complaint sample was returned to the manufacturing facility in an open pouch for investigation.Bronchial tube was inflated using a calibrated endotest obtained in the investigation lab for both clear and blue cuff.Both clear and blue cuff were able to be inflate as per normal and product able to maintain its pressure, no indication of leakage observed.Tracheal clear cuff was able to maintain its pressure at 25 mbar, bronchial blue cuff was able to maintain its pressure at 25 mbar.A device history record review was performed, and no relevant findings were identified.Based on the investigation, the defect mode of cuff leakage was not confirmed.Based on inflation test, no abnormality was found as product was able to be inflated as per normal.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that during a thoracic surgery, the bronchial cuff deflated, even after re-inflating the cuff.The cuff had been pretested prior to a successful intubation for a thoracic surgery.After the deflation was discovered during surgery, continuous monitoring of the cuff pressure was performed and regular re-inflation was performed to maintain pressure of the cuff.As a result, "there was poor ventilation of the patient during the procedure due to the lack of sealing of the cuff".Additional information received states that the "patient faced occasional and recurrent desaturations related to ventilatory difficulties.However, no other major clinical consequence for the patient".There was no information provided on the oxygen saturation percentages that the patient experienced.The current status of the patient is reported as "post-operative follow up without anything special for the current condition".

• Brand Name: DOUBLE LUMEN BRONC. TUBE SET CARINA H.
• Common Device Name: TUBE, BRONCHIAL (W/WO CONNECT
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17293824
• Report Number: 8040412-2023-00270
• Device Sequence Number: 4109534
• Product Code: BTS
• UDI-Device Identifier: 14026704344298
• UDI-Public: 14026704344298
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K951091
• 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): 06/13/2023

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: IPN047059
• Device Catalogue Number: 116101-000410
• Device Lot Number: KME22H3044
• 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: 06/13/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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