MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ET TUBE,CF,3.5; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN048865
Medical Device Problem Code	Dent in Material (2526)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.From the pictures, it was confirmed the defect reported by the customer "occlusion - kinked".However, it is necessary to receive the physical sample to perform a proper investigation, determine root cause & implement corrective actions.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 that "the anesthesia teacher used the product to perform surgical treatment on the patient.During bronchoscopy, it was found that the inner diameter of the product did not reach 3.5mm, bronchoscopy cannot go through and it could not be used normally".No patient injury or harm reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one unit 5-10107 et tube, cf, 3.5 for investigation.The returned et tube was visually examined with and witho ut magnification.Visual examination revealed that where the inflation line enters the tube, the inflation line sits lower inside the tube which causes an occlusion of the inner diameter of the tube.It could not be determined what caused this issue, but a non-conformance has been opened at the manufacturing site to further investigate this issue.
Event or Problem Description
It was reported that "the anesthesia teacher used the product to perform surgical treatment on the patient.During bronchoscopy, it was found that the inner diameter of the product did not reach 3.5mm, bronchoscopy cannot go through and it could not be used normally".No patient injury or harm reported.Patient condition reported as "fine".

• Brand Name: HUDSON ET TUBE,CF,3.5
• 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: 12908383
• Report Number: 3003898360-2021-01089
• Device Sequence Number: 3840167
• Product Code: BTR
• UDI-Device Identifier: 14026704616449
• UDI-Public: 14026704616449
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 11/08/2021

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: 03/16/2025
• Device Model Number: IPN048865
• Device Catalogue Number: 5-10107
• Device Lot Number: 73C2000266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2020
• 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: N/A.; N/A.
• Patient Sex: Unknown