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

Catalog Number	5-10315
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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 by clinicians at the hospital: leaking from ett tubes.It is taking a lot to fill the balloon, then the leaking issue arises." additional information from clinicians: the patient had low tidal volumes.The tube was exchanged, and patient was reintubated.The patient's current condition is deceased.Cause of death septic shock and respiratory failure.
Event or Problem Description
It was reported by clinicians at the hospital: leaking from ett tubes.It is taking a lot to fill the balloon, then the leaking issue arises." additional information from clinicians: the patient had low tidal volumes.The tube was exchanged, and patient was reintubated.The patient's current condition is deceased.Cause of death septic shock and respiratory failure.
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.Corrected data: dt changed to serious injury.

• 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: 18893690
• Report Number: 3003898360-2024-00241
• Device Sequence Number: 20702290
• Product Code: BTR
• UDI-Device Identifier: 04026704397044
• UDI-Public: 04026704397044
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5-10315
• Device Lot Number: 855
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 76 KG