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

Catalog Number	5-22312
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.
Event or Problem Description
It was reported that: "patient intubated x3 with "performed, cuffed tracheal tube, nasal" anesthesia states that the cuffs were checked prior to intubation.Cuffs did not hold air after intubation x3.Patient was then intubated orally.No harm to the patient was communicated." associated complaints 3003898360-2024-01071, 3003898360-2024-01072, 3003898360-2024-01113 and 3003898360-2024-01070.
Additional Manufacturer Narrative
(b)(4).Medwatch received 01-nov-2024.Uf/importer report# (b)(4).
Event or Problem Description
It was reported that: "patient intubated x3 with "performed, cuffed tracheal tube, nasal" anesthesia states that the cuffs were checked prior to intubation.Cuffs did not hold air after intubation x3.Patient was then intubated orally.No harm to the patient was communicated." associated complaints 3003898360-2024-01071, 3003898360-2024-01072, and 3003898360-2024-01070.

• 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: 20143262
• Report Number: 3003898360-2024-01113
• Device Sequence Number: 7398453
• Product Code: BTR
• UDI-Device Identifier: 04026704398102
• UDI-Public: (01)04026704398102(11)230919(17)280918(10)73J2300697(21)
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 5-22312
• Device Lot Number: 73L2300012
• 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: 08/12/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2023
• 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