MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH ENDOTRACHEAL TUBE - PLAIN - MURPHY - STR; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN040783
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Ventilator Dependent (2395)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "size of this et tube was a size 7 tube.Condition of the patient is on vent.No medical intervention needed.Patient did not experience desaturation.Problem was solved.They did not extubate or intubate.Clinicians are able to intubate the patient just fine.After an hour they notice that the connector pops off our et tube".No patient harm reported.Patient condition reported as "fine".
Event or Problem Description
It was reported "size of this et tube was a size 7 tube.Condition of the patient is on vent.No medical intervention needed.Patient did not experience desaturation.Problem was solved.They did not extubate or intubate.Clinicians are able to intubate the patient just fine.After an hour they notice that the connector pops off our et tube".No patient harm reported.Patient condition reported as "fine".
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.The connector assembly features of the et 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 a precaution stated in the ifu that the 15mm connector should be firmly seated in the tracheal tube to prevent disconnection during use.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.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.

• Brand Name: RUSCH ENDOTRACHEAL TUBE - PLAIN - MURPHY - STR
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11486200
• Report Number: 8040412-2021-00078
• Device Sequence Number: 3876953
• Product Code: BTR
• UDI-Device Identifier: 14026704340870
• UDI-Public: 14026704340870
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K961840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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: No Information
• Device Model Number: IPN040783
• Device Catalogue Number: 100382070
• Device Lot Number: 20GG36
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1