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

Model Number	IPN041504
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It is reported that "on multiple occasions, while in the middle of a surgical case, the detachable plastic piece on the top of the endotracheal tube has come off completely with the circuit attached while the patient is intubated.Last week this happened twice in the middle of our first case." after further correspondence with the reporter, the customer does not have any further information regarding the specifics of the events.If additional information is received, the complaint file will be updated.See associated mdrs 8040412-2023-00046, 8040412-2023-00047, 8040412-2023-00025, 8040412-2023-00048.
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It is reported that "on multiple occasions, while in the middle of a surgical case, the detachable plastic piece on the top of the endotracheal tube has come off completely with the circuit attached while the patient is intubated.Last week this happened twice in the middle of our first case." after further correspondence with the reporter, the customer does not have any further information regarding the specifics of the events.If additional information is received, the complaint file will be updated.Associated mdrs 8040412-2023-00046, 8040412-2023-00047, 8040412-2023-00025, 8040412-2023-00048.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16272613
• Report Number: 8040412-2023-00049
• Device Sequence Number: 18015399
• Product Code: BTR
• UDI-Device Identifier: 14026704341440
• UDI-Public: 14026704341440
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K961837
• 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): 01/18/2023

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 Expiration Date: 08/28/2026
• Device Model Number: IPN041504
• Device Catalogue Number: 112082080
• Device Lot Number: KME21J1295
• 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: 01/31/2023
• Supplement Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• 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