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

Model Number	IPN040969
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "doctor opened the product and put air in it up to 40cc.After then, found leakage on balloon".No patient injury or harm reported.Patient condition reported as "fine".
Event or Problem Description
It was reported that "doctor opened the product and put air in it up to 40cc.After then, found leakage on balloon".No patient injury or harm reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was then performed and the cuff and pilot balloon were inflated to 25mbar using a calibrated endotest meter.The cuff could not stay inflated.The sample was then immersed in water for leak testing.Air bubbles were observed coming from the pilot balloon indicating there was a leak.The sample was then observed under a magnifying camera and a tear mark on the side arm pilot balloon was observed.A device history record review was performed and no relevant findings were identified.The complaint of leakage was confirmed; however, a root cause for the issue could not be determined.There is 100% inflation and leak testing conducted during the manufacturing process whereby any leakage would be detected prior to release from the manufacturing facility.

• 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
• 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: 12798725
• Report Number: 8040412-2021-00279
• Device Sequence Number: 17539989
• Product Code: BTR
• UDI-Device Identifier: 14026704340962
• UDI-Public: 14026704340962
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 10/19/2021

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: 11/28/2024
• Device Model Number: IPN040969
• Device Catalogue Number: 103902-000070
• Device Lot Number: 19LT43
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 12/08/2021
• 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