MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH LASER TRACHEAL TUBE; TUBE, TRACHEAL (W/WO CONNECTO

Model Number	IPN040897
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Fluid Discharge (2686)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
It was reported that "patient: male.Outer cuff begins leaking perioperatively.It was filled with water as prescribed.The cuff begins leaking in the middle of the operation.No explanation when the position of the tube was inspected using video optics.It was not possible to get this sealed and it was changed to a standard tube and the operation was completed without complication.Clinical consequences: none, as the event was avoided".No patient harm or injury reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
(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 was reported that "patient: male.Outer cuff begins leaking perioperatively.It was filled with water as prescribed.The cuff begins leaking in the middle of the operation.No explanation when the position of the tube was inspected using video optics.It was not possible to get this sealed and it was changed to a standard tube and the operation was completed without complication.Clinical consequences: none, as the event was avoided".No patient harm or injury reported.Patient condition reported as "fine".

• Brand Name: RUSCH LASER TRACHEAL TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTO
• Manufacturer (Section D): TELEFLEX MEDICAL; 71394 kernen
• MDR Report Key: 11592099
• Report Number: 9610520-2021-00004
• Device Sequence Number: 19706979
• Product Code: BTR
• UDI-Device Identifier: 04026704002641
• UDI-Public: 04026704002641
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K935842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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 Expiration Date: 12/31/2021
• Device Model Number: IPN040897
• Device Catalogue Number: 102004-000040
• Device Lot Number: 21031
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1