MAUDE Adverse Event Report: TELEFLEX MEDICAL DOUBLE LUMEN BRONCHIAL TUBE SET LEFT; TUBE, BRONCHIAL (W/WO CONNECT

Model Number	IPN041703
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the doctor found a cuff leak while in use on the patient.The doctor changed to a new tube.The patient did not experience any desaturation.No report of patient harm or injury.
Additional Manufacturer Narrative
Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.
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.
Event or Problem Description
It was reported that the doctor found a cuff leak while in use on the patient.The doctor changed to a new tube.The patient did not experience any desaturation.No report of patient harm or injury.

• Brand Name: DOUBLE LUMEN BRONCHIAL TUBE SET LEFT
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15771386
• Report Number: 8040412-2022-00323
• Device Sequence Number: 6508974
• Product Code: BTS
• UDI-Device Identifier: 14026704344250
• UDI-Public: 14026704344250
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K951091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2022

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
• Operator of Device: Health Professional
• Device Model Number: IPN041703
• Device Catalogue Number: 116100-000370
• Device Lot Number: KME20M2240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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