MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH SAFETY CLR MURPHY CUF ET; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN041503
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reported issue: while the endotracheal tube was being used it was not possible to deflate the balloon disconnecting line.It was removed from the patient with the balloon still inflated.
Additional Manufacturer Narrative
Qn# (b)(4).The device investigation is pending.The results will submitted in a follow-up report.
Additional Manufacturer Narrative
(b)(4).The actual device, along with 5 representative samples were received for investigation.A visual exam was performed, and it was observed that the actual sample did not have a connector or the pilot balloon (the side arm was cut).No issues were observed with the representative samples.Inflation and deflation testing was performed on the representative samples and no issues were encountered.Functional testing could not be performed on the actual device due to the damage.A device history record review was performed and no relevant findings were identified.The complaint could not be confirmed due to the condition of the returned device.
Event or Problem Description
Reported issue: while the endotracheal tube was being used it was not possible to deflate the balloon disconnecting line.It was removed from the patient with the balloon still inflated.

• Brand Name: RUSCH SAFETY CLR MURPHY CUF ET
• 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 ; 9194332672
• MDR Report Key: 16648685
• Report Number: 8040412-2023-00131
• Device Sequence Number: 6097541
• Product Code: BTR
• UDI-Device Identifier: 14026704341433
• UDI-Public: 14026704341433
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K961837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2023

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: IPN041503
• Device Catalogue Number: 112082075
• Device Lot Number: KME22A1990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown