MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ET TUBE,CF,4.5; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-10109
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
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.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 inflating tube was found almost detached upon opening the package.Therefore, a new kit was used instead." the issue was found prior to use.There was no patient involved.
Event or Problem Description
It was reported that: "the inflating tube was found almost detached upon opening the package.Therefore, a new kit was used instead." the issue was found prior to use.There was no patient involved.
Additional Manufacturer Narrative
(b)(4).The customer returned one unit 5-10109 et tube, cf, 4.5 for investigation.The et tube was visually examined with and without magnification.Visual examination of the returned device revealed that the inflation line was loose from the tube.The notch on the tube appears slightly stretched upward which is an indication that the inflation line might have been pulled out of the tube.Additionally, there was a hole in the notch of the tube where the inflation line enters the tube.The hole would cause a leak and prevent proper ventilation during use.The manufacturing site was consulted for this investigation.It could not be determined what caused this issue to occur.Since the sample was returned out of its original packaging, it could not be confirmed if the inflation line was loose when it left manufacturing.A device history record review was performed and no relevant findings were identified.The reported complaint was confirmed based upon the sample received.A non conformance was previously opened by the manufacturing site to further investigate the hole in the notch.The hole in the notch was caused by an incorrect insertion of the pin that creates the notch during manufacturing.Corrective actions were implemented on 18 april 2023 to help prevent this issue from recurring.The manufacturing site was consulted for this investigation.It could not be determined what caused the inflation line to detach from the et tube.Since the sample was returned out of its original packaging, it could not be confirmed if the inflation line was loose when it left manufacturing.A device history record review was performed with no evidence to suggest a manufacturing related cause.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, the root cause of this complaint issue is unknown.Teleflex will continue to monitor and trend on this issue.

• Brand Name: HUDSON ET TUBE,CF,4.5
• 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: 19526953
• Report Number: 3003898360-2024-00714
• Device Sequence Number: 7513063
• Product Code: BTR
• UDI-Device Identifier: 04026704396757
• UDI-Public: 04026704396757
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/20/2024

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
• Device Catalogue Number: 5-10109
• Device Lot Number: 73C2300042
• 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: 05/20/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2023
• 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