MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH CRVD REINF CUFF ET 7.0MM; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	IPN040970
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that "the doctor found the cuff leaking during the operation and tried 2 times to use the same lot of product but found the same issue on products, the patient status is unknown".
Event or Problem Description
It was reported that "the doctor found the cuff leaking during the operation and tried 2 times to use the same lot of product but found the same issue on products, the patient status is unknown".
Additional Manufacturer Narrative
Qn# (b)(4).It was reported that the sample is not available for return; therefore, ten samples were selected from current production at the manufacturing facility for evaluation.A visual exam was conducted and no defects were observed.The cuff pressure was then tested on the samples and the cuffs on all ten samples could be inflated without any issues and they maintained pressure at 25mbar with no abnormalities.The production samples were then immersed in water for leak testing.No bubbles were observed flowing out from the samples during the underwater test indicating there were no leaks.There is 100% leak testing performed in manufacturing in which any leakage would be identified prior to release from the manufacturing facility.Simulation using production (representative) samples showed no decrease in cuff pressure and no leakage at the side arm joint was observed.A device history record review was performed and no relevant findings were identified.Without the actual 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 CRVD REINF CUFF ET 7.0MM
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 12053433
• Report Number: 8040412-2021-00168
• Device Sequence Number: 14555760
• Product Code: BTR
• UDI-Device Identifier: 14026704340979
• UDI-Public: 14026704340979
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2021

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 Expiration Date: 10/28/2024
• Device Model Number: IPN040970
• Device Catalogue Number: 103902-000070
• Device Lot Number: 19KT38
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1