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	Unspecified Tissue Injury (4559)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported: "the endotracheal tubes are very stiff which causes airway injuries upon insertion, requiring the patient to be reintubated.The patient's current condition is reported as "fine".Associated mdr number 8040412-2024-00059.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The sample was not returned to the manufacturer.The manufacturer reported: "visual, dimensional and functional inspection could not be conducted as no physical complaint sample was returned for investigation.The device lot number was not provided; therefore, a dhr review could not be conducted.Further investigation could not be conducted without the returned sample.Thus, this complaint could not be confirmed." teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported: "the endotracheal tubes are very stiff which causes airway injuries upon insertion, requiring the patient to be reintubated.The patient's current condition is reported as "fine".Associated mdr number 8040412-2024-00059.

• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19002550
• Report Number: 8040412-2024-00100
• Device Sequence Number: 13104556
• Product Code: BTR
• UDI-Device Identifier: 14026704341426
• UDI-Public: 14026704341426
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/05/2024

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
• 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: 03/05/2024
• Supplement Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 04/30/2024
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown