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

Model Number	IPN041498
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Reported event: the patient who is under invasive mechanical ventilation, balloon not inflated, oro-intubated with a number 5.0 orotracheal cannula with a balloon fixed 12 cm from the dental arch at 6:30 a.M.On 10-17-22 an event of incidental extubation occurs, he is reintubated on the first attempt with cannula from number 5.0.
Additional Manufacturer Narrative
(b)(4).There was no sample returned for investigation therefore complaint could not be confirmed as reported.Since there is no sample returned, previous similar complaint for this product code was reviewed.Visual inspection was conducted on actual sample returned for the similar complaint.It can be observed that the end tube was cut.From the photograph provided, it can be seen that the connector insertion depth of the actual sample is 8mm, which meet the criteria of the connector need to be partially inserted to the tube.The connector assembly features of the endotracheal tube were designed in such a way that the connector can be removed and connected back to the tube when the tube is 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.In conclusion, there was no sample returned for investigation therefore complaint could not be confirmed as reported.The connector assembly features of endotracheal tube were designed in such a way that the connector can be removed and connected back to the tube when the tube is required to be cut to length.Plus, there is precaution stated in the ifu that the 15mm connector should be firmly seated in the tracheal tube to prevent disconnected during use.
Event or Problem Description
Reported event: the patient who is under invasive mechanical ventilation, balloon not inflated, oro-intubated with a number 5.0 orot racheal cannula with a balloon fixed 12 cm from the dental arch at 6:30 a.M.On (b)(6) 2022 an event of incidental extubation occurs, he is reintubated on the first attempt with cannula from number 5.0.

• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16386427
• Report Number: 8040412-2023-00050
• Device Sequence Number: 12046644
• Product Code: BTR
• UDI-Device Identifier: 14026704341389
• UDI-Public: 14026704341389
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2023
• Device Model Number: IPN041498
• Device Catalogue Number: 112082050
• Device Lot Number: 18IT12
• 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: 01/18/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 03/28/2023
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown