MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH CRVD REINF CUFF ET 7.5MM; 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	06/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "the doctor found cuff leakage during clinical setting before using on patient.No impact on patient.".
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 cuff indicating there was a leak.The area of leakage was observed under magnification and a cut mark was observed on the cuff.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 a 100% leak test and visual inspection conducted at the manufacturing facility whereby any leakage would be detected prior to release.It is possible that the failure could be induced during product handling by the user, although this could not be confirmed.
Event or Problem Description
It was reported that: "the doctor found cuff leakage during clinical setting before using on patient.No impact on patient.".

• Brand Name: RUSCH CRVD REINF CUFF ET 7.5MM
• 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 ; 9193614124
• MDR Report Key: 15105094
• Report Number: 8040412-2022-00215
• Device Sequence Number: 4213947
• Product Code: BTR
• UDI-Device Identifier: 14026704340979
• UDI-Public: 14026704340979
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2022

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 Model Number: IPN040970
• Device Catalogue Number: 103902-000075
• Device Lot Number: 20ET50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown