MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE, HVT, 7.5; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN926930
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reported via medwatch, "patient admitted to the sicu status post open-heart surgery.Brought to unit intubated, during time on the icu ett (endotracheal tube) popped off multiple times as described in recent recall.Ett appeared to be the old tube which was recalled.Old tubes were supposed to have been swapped out.Patient became unstable and needed emergent ct scan, tube required tape to stay in place in order to safely travel to scan.Etco2 (end-tidal carbon dioxide) was used at all times." additional information was asked to the customer regarding patient harm or injury and current condition, as well as details surrounding the event.The customer responded but did not have answers to any of these questions.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be completed as no lot number was 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.

• Brand Name: ET TUBE, HVT, 7.5
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17341663
• Report Number: 3003898360-2023-01103
• Device Sequence Number: 6903457
• Product Code: BTR
• UDI-Device Identifier: 14026704759252
• UDI-Public: 14026704759252
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Report Date (Section B): 06/26/2023

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: IPN926930
• Device Catalogue Number: 5-10315
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 07/18/2023
• 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
• Patient Sex: Unknown