MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ET TUBE, HVT, 6.5; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN048894
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "[pilot balloon] was deformed so [it] could not [be] used".No patient involvement reported.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.After review of one picture provided by the customer, it was confirmed the defect reported by the customer.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported "[pilot balloon] was deformed so [it] could not [be] used".No patient involvement reported.
Additional Manufacturer Narrative
(b)(4).The customer returned one unit 5-10313 et tube, hvt, 6.5 for investigation.The returned et tube was visually examined with and without magnification.Visual examination of the returned et tube revealed that the pilot valve was severely damaged as it was pressed shut.This damage would prevent a syringe from attaching to the pilot valve and inflating the device.A non-conformance has been opened to further investigate this complaint issue.

• Brand Name: HUDSON ET TUBE, HVT, 6.5
• 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: 13446622
• Report Number: 3003898360-2022-00013
• Device Sequence Number: 4321719
• Product Code: BTR
• UDI-Device Identifier: 14026704616739
• UDI-Public: 14026704616739
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2022

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 Expiration Date: 12/09/2024
• Device Model Number: IPN048894
• Device Catalogue Number: 5-10313
• Device Lot Number: 73M1900246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2019
• 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
• Patient Sex: Unknown