MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. FLEXI-SET CUFFED 7.5MM; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN044686
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reported issue: pilot balloon found to be out of ett.It is not clear if it was pulled or bit off.No alarms on the ventilator were activated.
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Additional Manufacturer Narrative
(b)(4).Additional information received: the patient needed to be re-intubated; there was no harm or other consequences.The device has not been returned for investigation.Since there was no sample returned for investigation, one sample was retrieved from production lot for simulation purpose.Based on the investigation, the complaint on this complaint mode could not be confirmed.The device history review for (b)(6) leak test was conducted and no leak product was found.Physical evidence of failure was not available because no sample was returned.There is 100% inflation and deflation test during manufacturing in which if the pilot balloon detached shall be detected and culled out.
Event or Problem Description
Reported issue: pilot balloon found to be out of ett.It is not clear if it was pulled or bit off.No alarms on the ventilator were activated.

• Brand Name: FLEXI-SET CUFFED 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16099108
• Report Number: 8040412-2023-00004
• Device Sequence Number: 6669289
• Product Code: BTR
• UDI-Device Identifier: 04026704547623
• UDI-Public: 04026704547623
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 12/19/2022

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
• Operator of Device: Health Professional
• Device Model Number: IPN044686
• Device Catalogue Number: 504575
• 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: 12/19/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 02/01/2023
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown