MAUDE Adverse Event Report: TELEFLEX MEDICAL SHERIDAN ET TUBE, CUFFED, SPIRAL-FLEX 8.0; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-12616
Medical Device Problem Codes	Gas/Air Leak (2946); Pressure Problem (3012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: during a surgery doctor detected a leak in the tube balloon because it lost pressure.Additional information requested from the account.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: during a surgery doctor detected a leak in the tube balloon because it lost pressure.Additional information requested from the account.
Additional Manufacturer Narrative
(b)(4).Failure mode "leak - device leak - cuff" could be confirmed with picture attached.However, it is necessary to receive the physical sample to perform a proper investigation, determinate the root cause & corrective actions.A device history record review was performed, and no relevant findings were identified.If the complaint samples become available at a later date, this complaint will be updated accordingly.
Event or Problem Description
It was reported that: during a surgery doctor detected a leak in the tube balloon because it lost pressure.Additional information requested from the account.
Additional Manufacturer Narrative
(b)(4).In section d provided the full udi # **udi related data quality updates only**.Additionally added the brand name of the device.

• Brand Name: SHERIDAN ET TUBE, CUFFED, SPIRAL-FLEX 8.0
• 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18281158
• Report Number: 3003898360-2023-01577
• Device Sequence Number: 20399143
• Product Code: BTR
• UDI-Device Identifier: 04026704397426
• UDI-Public: (01)04026704397426(11)230523(17)280522(10)73E2300870(21)
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K844296
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2023

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 Catalogue Number: 5-12616
• Device Lot Number: 73E2300870
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 11/30/2023; Not provided
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 01/04/2024; 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2023
• 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; NOT REPORTED
• Patient Sex: Unknown