MAUDE Adverse Event Report: PORTEX; TRACHEAL TUBE

Model Number	H4021S
Medical Device Problem Codes	Fracture (1260); Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/15/2021
Type of Reportable Event	Death
Event or Problem Description
Information was received indicating that a smiths medical endotracheal tube had a "small pin hole crack" towards the middle of the tube which was discovered upon removal.Patient was a premature infant who had complications following birth leading to intubation with a smiths medical endotracheal tube and the use of a conventional ventilator on (b)(6) 2021.Patient continued to do poorly and was then placed on an oscillator ventilator, where the patient did not improve and thus was returned to the conventional ventilator.During this time, clinicians believed that the tube was causing leaks in certain positions and decided to change to a new tube.It was reported that following removal of the tube for replacement, the small pin hole crack? was noted.The new tube was placed, but the patient did not improve and eventually coded and passed away on (b)(6) 2021.Official cause of death is unknown, further information has been requested and a supplemental report will be filed should further information be received.

• Brand Name: PORTEX
• Common Device Name: TRACHEAL TUBE
• MDR Report Key: 12507205
• Report Number: 3012307300-2021-09498
• Device Sequence Number: 5338288
• Product Code: BTR
• UDI-Device Identifier: 15019315077579
• UDI-Public: 15019315077579
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2021

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 Expiration Date: 05/21/2023
• Device Model Number: H4021S
• Device Lot Number: 3987029
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 09/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2020
• 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
• Outcome Attributed to Adverse Event: Death