MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE, PREFORMED CUFFED NASAL, 7.0; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-22314
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/14/2024
Type of Reportable Event	Malfunction
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 was reported that: "we have received complaints of cuff leaks on these tubes." additional information has been requested.Associated to 3003898360-2024-00317.
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: "we have received complaints of cuff leaks on these tubes." additional information has been requested.Associated to 3003898360-2024-00317.

• Brand Name: ET TUBE, PREFORMED CUFFED NASAL, 7.0
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19069287
• Report Number: 3003898360-2024-00318
• Device Sequence Number: 4658818
• Product Code: BTR
• UDI-Device Identifier: 04026704398102
• UDI-Public: 04026704398102
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

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: 5-22314
• Device Lot Number: 73K2300653
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2023
• 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: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown