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

Catalog Number	504575
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "after inserting in the patient, they tried to inflate and the tube failed.It appeared to have a leak.There was a hole in it.Patient had to be extubated and re intubated.".
Event or Problem Description
It was reported that "after inserting in the patient, they tried to inflate and the tube failed.It appeared to have a leak.There was a hole in it.Patient had to be extubated and reintubated.".
Additional Manufacturer Narrative
Qn# (b)(4).The reported complaint of cuff leakage was confirmed upon investigation of the returned sample.The customer returned the actual sample for investigation.Visual inspection of the sample returned confirmed a tear on the cuff with features consistent with a burst type rupture, likely associated with internal pressurization or localized material weakness.No evidence of damage from sharp instruments was observed.A device history record review was performed, and no relevant findings were identified.While the instructions for use (ifu) caution against overinflation and recommend pre-use cuff testing, the specific root cause of the defect could not be determined based on the available evidence.

• Brand Name: RUSCH 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22518093
• Report Number: 8040412-2025-00178
• Device Sequence Number: 12919877
• Product Code: BTR
• UDI-Device Identifier: 04026704547623
• UDI-Public: (01)04026704547623(11)241110(17)291031(10)40E24L1429(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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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: 504575
• Device Lot Number: 40E24L1429
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2024
• 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