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

Catalog Number	112082070
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Sore Throat (2396)
Date of Event	05/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the tip of the tubes are very stiff, concern about unnecessary trauma to cords/larynx.The balloon is also stiff and difficult to pass through the cords.Catches on the cords when trying to advance the tube." additional information received on may 21, 2026, indicated that "the issue occurred on going from mid april until now, during use in patient, having to have multiple attempts to intubate.Sore throats being reported more often than usual.Patient's current condition unknown, multiple patients involved.".

• Brand Name: 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 25491000
• Report Number: 8040412-2026-00090
• Device Sequence Number: 18754246
• Product Code: BTR
• UDI-Device Identifier: 14026704341426
• UDI-Public: (01)14026704341426(11)251110(17)301031(10)40E25L1675
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K961837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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: 112082070
• Device Lot Number: 40E25L1675
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/07/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Supplement Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2025
• 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.
• Patient Sex: Unknown