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	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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." associated complaints 3003898360-2024-01071, 3003898360-2024-01072, 3003898360-2024-01113 and 3003898360-2024-01070.
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." associated complaints 3003898360-2024-01071, 3003898360-2024-01072, 3003898360-2024-01113 and 3003898360-2024-01070.
Additional Manufacturer Narrative
(b)(4).The customer returned one unit 5-22314 et tube, preformed cuffed nasal, 7.0 for investigation.The et tube was visually examined with and without magnification.Visual examination of the returned device revealed that the balloon cuff had multiple holes.There was a large hole as it appeared like the cuff was cut by something sharp.Another slice mark was present on the cuff which caused multiple small holes in the cuff.A device history record review was performed and no relevant findings were identified.The ifu for this product states, "the tracheal tube cuff inflation system, including the valve, should be checked prior to intubation.If a malfunction is a detected in any part of the system, the tube should not be used." "care should be taken to avoid damaging the thin-walled cuffs during intubation.If cuff is damaged, the tube should not be used." the ifu also states, "cuff pressure should be monitored routinely to assure that an adequate tracheal seal is maintained and that the cuff has not become over-inflated.The tracheal tube cuff should be slowly inflated with the minimum amount of air required to provide an effective tracheal seal.Do not inflate with a measured volume of air or by "feel" of pressure in the syringe since little resistance should be felt during inflation." the reported complaint was confirmed based upon the sample received.Visual examination of the returned device revealed that the balloon cuff had multiple holes which would prevent it from inflating.There was a large hole as it appeared like the cuff was cut by something sharp.Another slice mark was present on the cuff which caused multiple small holes in the cuff.All et tubes are 100% inspected for inflation and deflation at the time of manufacturing.It is unlikely that this type of damage was present at the time of manufacturing.Therefore, based upon the damage observed, unintentional user error caused or contributed to this event.
Additional Manufacturer Narrative
Qn# (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." associated complaints 3003898360-2024-01071, 3003898360-2024-01072, 3003898360-2024-01113 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: 20105675
• Report Number: 3003898360-2024-01071
• Device Sequence Number: 7869762
• 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 Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2024

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: 5-22314
• Device Lot Number: 73J2300697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2024
• Supplement Date Received by Manufacturer: 09/06/2024; Not provided
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 09/16/2024; 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• 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