MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH DOUBLE LUMEN BRONC. TUBE SET RIGHT; TUBE, TRACHEAL/BRONCHIAL, DIFFERENTI

Model Number	IPN041720
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "the doctor found cuff leakage when using on patient.Then changed new one, no impact on patient." the patient status is reported as "fine".
Event or Problem Description
It was reported that "the doctor found cuff leakage when using on patient.Then changed new one, no impact on patient." the patient status is reported as "fine".
Additional Manufacturer Narrative
(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 (dhr) review was performed and there were no issues found that could relate to the reported complaint.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.

• Brand Name: RUSCH DOUBLE LUMEN BRONC. TUBE SET RIGHT
• Common Device Name: TUBE, TRACHEAL/BRONCHIAL, DIFFERENTI
• 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: 16886214
• Report Number: 8040412-2023-00202
• Device Sequence Number: 17677563
• Product Code: CBI
• UDI-Device Identifier: 14026704344335
• UDI-Public: 14026704344335
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 04/12/2023

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: IPN041720
• Device Catalogue Number: 116200-000370
• Device Lot Number: 18IT23
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 06/02/2023
• 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