MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ET TUBE, HVT, 8.0; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN926931
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/29/2023
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 could not be conducted since the lot number was not provided.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.
Event or Problem Description
It was reported that while in use on a patient, the hub disconnected."the connector/hub was pushed in prior to intubation and still came out." no patient harm or injury.Per the customer, the patient current patient status is unknown.At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one unit 5-10316 et tube, hvt, 8.0 for investigation.The sample was returned without its original packaging.The returned sample was visually examined with and without magnification.Visual examination revealed that the sample appears used as there is biological material present on the device.There is tape on the proximal end of the tube where the connector is.The connector was not inserted to the proper insertion depth.It appeared that the connector was only inserted as far as it was during manufacturing.There are no indentations in the tube that would indicate the connector was ever inserted further into the tube, as per the ifu.The distal end of the connector (the part of the connector that inserts into the tube) had adhesive residue on it and was cracked.Functional inspection was performed to test proper insertion of the connector.The connector was able to be inserted further into the tube, but it was able to be easily removed due to the adhesive residue on the connector as well as the crack that prevented the connector from holding firmly in the tube.The ifu for this product states, "the 15 mm connector may be loosely seated due to the relaxation of the tube material around the connector.Seat the connector firmly in the tracheal tube.For a secure connection, the contacting surfaces must be clean and dry when seating the connector." "seat the 15 mm connector firmly in the adapter on the ventilator equipment to prevent disconnection during use.Ordinarily the security of the connection is increased by twisting the two elements together." "non-standard dimensions of some connectors on ventilator or anesthesia equipment may make it difficult to securely mate with the tracheal tube 15 mm connector.Use only the equipment having 15 mm connectors that are standard in compliance with iso 5356-1." the reported complaint was confirmed based upon the sample received.Based on the condition of the returned sample, it appears that the end user did not follow the ifu.Therefore, the root cause of this complaint is user error.A customer in-service has been requested to instruct the user on proper use of this device.
Event or Problem Description
It was reported that while in use on a patient, the hub disconnected."the connector/hub was pushed in prior to intubation and still came out." no patient harm or injury.Per the customer, the patient current patient status is unknown.At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

• Brand Name: HUDSON ET TUBE, HVT, 8.0
• 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: 16953991
• Report Number: 3003898360-2023-00757
• Device Sequence Number: 3301343
• Product Code: BTR
• UDI-Device Identifier: 14026704759269
• UDI-Public: 14026704759269
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 04/27/2023

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 Model Number: IPN926931
• Device Catalogue Number: 5-10316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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