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

Catalog Number	112082070
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "rusch '7.0 endotracheal tube inserted without issue, unable to ventilate mechanically or manually.High pressure alarms present." the patient was reintubated.There was no patient harm or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn # (b)(4).
Additional Manufacturer Narrative
(b)(4).A sample was returned to the manufacturer for evaluation.The manufacturer reported: "one actual sample was returned for evaluation.Visual inspection was performed on the returned actual complaint sample.No other abnormality found for sample.Functional inspection was performed.The cuff pressure of the actual returned sample was inflated to 25mbar by using calibrated endotest.The endotest was able to maintain its pressure at 25mbar.Further inspection carried out by inserting the whole tube inside water for leak test.From the testing, there is no bubble flowing out from the tube which indicates no leaking found.Based on the investigation conducted, the complaint on issue unable to ventilate mechanically or manually could not be confirmed.A device history record review was performed, and no relevant findings were identified.Based on investigation and testing conducted, no defect observed from the sample returned.There were no bubbles flowing out from cuff, side arm and pilot balloon which indicates no leakage on the product.The returned complaint device meets manufacturing release specifications.The complaint is not confirmed, and the root cause was not determined." teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "rusch '7.0 endotracheal tube inserted without issue, unable to ventilate mechanically or manually.High pressure alarms present." the patient was reintubated.There was no patient harm or injury.The patient's current condition is reported as "fine".

• Brand Name: RUSCH 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: 19861308
• Report Number: 8040412-2024-00175
• Device Sequence Number: 12638722
• Product Code: BTR
• UDI-Device Identifier: 14026704341426
• UDI-Public: (01)14026704341426(11)230822(17)280731(10)40E23H3765(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K961837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2024

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
• Device Catalogue Number: 112082070
• Device Lot Number: 40E23H3765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2023
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown