MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; ENDROTRACHEAL

Model Number	100/179/065
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical intubation|portex endotracheal tubes was involved in a event with nasal intubation when the bladder was found to leak, event though checked twice.No patient adverse events reported.

• Brand Name: PORTEX
• Common Device Name: ENDROTRACHEAL
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 12033329
• Report Number: 3012307300-2021-06327
• Device Sequence Number: 14446938
• Product Code: BTR
• UDI-Device Identifier: 15019315022111
• UDI-Public: 15019315022111
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2021

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: No Information
• Device Expiration Date: 06/05/2024
• Device Model Number: 100/179/065
• Device Catalogue Number: 100/179/065
• 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: 05/25/2021
• Initial Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1