MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. NASORAL UNCUF MURPHY ET 3; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN040776
Medical Device Problem Codes	Failure to Disconnect (2541); Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "we were unable to remove the hub from the endotracheal tube".No patient harm or injury.The patient status is reported as "fine".Additional information received states that the indication for use of the ett was that the patient required mechanical ventilation with medical management in critical care.The issue was resolved by cutting the ett to remove the adaptor.The patient did not require reintubation.The patient did not experience any oxygen desaturation.
Additional Manufacturer Narrative
Qn#(b)(4) the reported complaint of 15 mm connector on ett have difficulty to be removed from tube was not confirmed based upon the sample received.Visual inspection and measurement for the connector insertion mark at tube was performed to check if connector was initially assembled followed the standard dimension as per product drawing.Upon dimensional inspection, not much force was required to pull out the 15mm connector from the tube.The connector met all the product requirement and dimension specifications.Additionally, the connector assembly features of et tube were designed in such a way that the connector can be removed and connected back to the tube when the tube required to be cut to length.There is precaution stated in the ifu that the 15mm connector should be firmly seated in the tracheal tube to prevent disconnected during use.A dhr review was performed, and no evidence was found to suggest a manufacturing related cause.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a corrected data: n/a.
Event or Problem Description
It was reported that "we were unable to remove the hub from the endotracheal tube".No patient harm or injury.The patient status is reported as "fine".Additional information received states that the indication for use of the ett was that the patient required mechanical ventilation with medical management in critical care.The issue was resolved by cutting the ett to remove the adaptor.The patient did not require reintubation.The patient did not experience any oxygen desaturation.

• Brand Name: NASORAL UNCUF MURPHY ET 3
• 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 27560
• MDR Report Key: 17040330
• Report Number: 8040412-2023-00229
• Device Sequence Number: 20461871
• Product Code: BTR
• UDI-Device Identifier: 14026704340801
• UDI-Public: 14026704340801
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K961840
• 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): 05/10/2023

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: IPN040776
• Device Catalogue Number: 100382035
• Device Lot Number: KME22L2341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2022
• 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
• Patient Sex: Unknown