MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. CURVED REINFORCED ENDOTRACHEAL TUBE; CRVD REINF CUFF ET 3.5MM

Model Number	IPN040962
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "the doctor found cuff cannot be inflated during clinical setting before using on patient.Then stopped and changed new one.No impact on patient.".
Additional Manufacturer Narrative
Qn#(b)(4).The actual sample was not returned; 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 the 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.
Event or Problem Description
It was reported that: "the doctor found cuff cannot be inflated during clinical setting before using on patient.Then stopped and changed new one.No impact on patient.".

• Brand Name: CURVED REINFORCED ENDOTRACHEAL TUBE
• Common Device Name: CRVD REINF CUFF ET 3.5MM
• 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: 15092313
• Report Number: 8040412-2022-00193
• Device Sequence Number: 5048944
• Product Code: BTR
• UDI-Device Identifier: 14026704340894
• UDI-Public: 14026704340894
• 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): 06/27/2022

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: 07/28/2025
• Device Model Number: IPN040962
• Device Catalogue Number: 103902-000035
• Device Lot Number: KME20H0674
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 08/12/2022
• 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