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

Catalog Number	V5-10116
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported "connector/hub issue.Apparently it came out unexpectedly." the current status of the patient is "unknown" at this time.Additional information was requested, further information is unavailable at this time.
Event or Problem Description
It was reported "connector/hub issue.Apparently it came out unexpectedly." the current status of the patient is "unknown" at this time.Additional information was requested, further information is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).The customer returned one unit v5-10116 et tube,cf,8.0 for investigation.The returned et tube was visually examined with and without magnification.Visual examination of the returned et tube revealed that the sample appeared used as there was biological material present on the device.The connector was not firmly inserted into the et tube.The returned connector was found to be broken/cracked on the distal end.It could not be determined how or when this damage occurred.The ifu for this product states, "the 15mm connector is loosely seated due to the relaxation of the tube material around the connector." "firmly 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 15mm 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 dimensioning of some connectors on ventilator or anesthesia equipment may make it difficult to securely mate with the tracheal tube 15mm connector.Use only the equipment having 15mm connectors that are standard, in compliance with iso 5356-1." the reported complaint was confirmed based on the returned sample.The returned connector was broken/cracked on the distal end.However, it could not be determined how or when this damage occurred.Teleflex will continue to monitor and trend on this issue.

• Brand Name: ET TUBE,CF,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: 19069507
• Report Number: 3003898360-2024-00376
• Device Sequence Number: 4658282
• Product Code: BTR
• UDI-Device Identifier: 04026704588763
• UDI-Public: 04026704588763
• 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,Followup
• Report Date (Section B): 03/18/2024

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: V5-10116
• Device Lot Number: NONE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 04/26/2024
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown