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

Catalog Number	5-10316
Medical Device Problem Codes	Disconnection (1171); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that: "patient was intubated with the et tube.No difficulties during the intubation.Shortly after patient was intubated the hub disconnected from the ett several times.Patient was scheduled for transport and hub disconnected during that time.Hub was taped to help prevent further disconnections.No harm reached patient due to rn and rt at bedside.Hub is currently having to be secured with tape." there was no reported patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).The customer returned one unit 5-10315 et tube, hvt, 7.5 for investigation.The returned et tube was visually examined with and with out magnification.Visual examination of the returned et tube revealed that the connector was seated into the tube.The connector is originally seated loosely in the tube and not seating the connector firmly into the tube before use can cause it to disconnect.It could not be determined if the connector was seated properly per the ifu prior to disconnecting during use.The returned sample appeared used as there was biological material present on the device.Dimensional inspection was performed on multiple dimensions of the connector.The inner and outer diameters at multiple locations on the connector were measured with reference to the product drawing.The inner diameter at the distal tip was measured to be between 0.2935-0.297" which is inside of the specification (0.295" +/- 0.002").The outer diameter at the distal tip was measured to be between 0.333"-0.336" which is inside of the specification (0.335" +/- 0.005") on the lower end.The inner diameter at the proximal end of the connector was measured to be 0.4605" which is within the specification (0.458" +/- 0.005").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." the reported complaint could not be confirmed based on the returned sample.The returned connector was found to be within the acceptable specifications.However, preventative actions have been previously implemented at the manufacturing site to prevent this issue from occurring.A vision system was implemented on 04jul2022 to check for proper insertion depth of the connector.Procedures were also updated at the same time to add further inspection points and testing during production to ensure connectors are within specification.A lot number was not provided for this returned sample and no potential lot number could be found.Therefore, it could not be determined if the returned sample was manufactured prior to or after these preventative actions.Teleflex will continue to monitor and trend on this issue.

• Brand Name: 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19275727
• Report Number: 3003898360-2024-00448
• Device Sequence Number: 15036881
• Product Code: BTR
• UDI-Device Identifier: 04026704397051
• UDI-Public: 04026704397051
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2024

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: 5-10316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2024
• Initial Report FDA Received Date: 05/09/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.
• Patient Sex: Unknown