MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH DOUBLE LUMEN BRONCHIAL TUBE SET LEFT

Model Number	IPN041702
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "cuff rupture of the broncho part[of] endotracheal tube during patient intubation".No patient injury or harm reported.Patient condition unknown at time of report.
Additional Manufacturer Narrative
Qn#(b)(4).The actual sample involved in the complaint was not returned for evaluation; therefore, a representative sample was taken from current production at the manufacturing facility.A visual exam was performed on the representative sample and no defects were observed.The blue cuff and the clear cuff were then inflated to 25mbar using a calibrated endotest.The cuffs were inflated and deflated with no issues.The sample was then immersed in water to check for leaks.No bubbles were observed coming from the cuffs indicating there were no leaks.A device history record review was performed and no relevant findings were identified.Although there were no issues found with the production sample, the complaint could not be confirmed as the actual sample is needed to perform a proper investigation and determine a root cause.
Event or Problem Description
It was reported "cuff rupture of the broncho part[of] endotracheal tube during patient intubation".No patient injury or harm reported.Patient condition unknown at time of report.

• Brand Name: RUSCH DOUBLE LUMEN BRONCHIAL TUBE SET LEFT
• Common Device Name: BRONCHIAL TUBE
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 14572600
• Report Number: 8040412-2022-00149
• Device Sequence Number: 5041891
• Product Code: CBI
• UDI-Device Identifier: 14026704344243
• UDI-Public: 14026704344243
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K141888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2022

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
• Device Expiration Date: 04/28/2025
• Device Model Number: IPN041702
• Device Catalogue Number: 116100390
• Device Lot Number: 20ET15
• 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: 04/29/2022
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 06/16/2022
• 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
• Patient Sex: Unknown