MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH FLEXI-SET CUFFED 7.0MM; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	504570
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "end user indicated kinking in ett.Physician indicated there are no patient health issues connected to the complaints.Product was pre-inflated for testing.Re-intubation and any desaturation of 02 are noted in case events.".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the 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: "end user indicated kinking in ett.Physician indicated there are no patient health issues connected to the complaints.Product was pre-inflated for testing.Re-intubation and any desaturation of 02 are noted in case events.".

• Brand Name: RUSCH FLEXI-SET CUFFED 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21661421
• Report Number: 8040412-2025-00078
• Device Sequence Number: 15540497
• Product Code: BTR
• UDI-Device Identifier: 04026704547616
• UDI-Public: (01)04026704547616(11)240618(17)290531(10)40E24F2626(21)
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K961837
• Number of Events Summarized: 1
• Summary Report (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): 02/28/2025

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 Catalogue Number: 504570
• Device Lot Number: 40E24F2626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2024
• 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: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown