MAUDE Adverse Event Report: PORTEX; ENDROTRACHEAL

Model Number	H4021S
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical intubation|portex endotracheal tube reported the small white screw on cap at the side of the et tube was not removed by a staff and the first instance involved a whole new ventilation circuit being used, staff could not identify why the circuit was not working.No patient adverse events reported.

• Brand Name: PORTEX
• Common Device Name: ENDROTRACHEAL
• MDR Report Key: 11858729
• Report Number: 3012307300-2021-04739
• Device Sequence Number: 19580769
• Product Code: BTL
• UDI-Device Identifier: 15019315077579
• UDI-Public: 15019315077579
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/20/2021

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 Model Number: H4021S
• Device Catalogue Number: H4021S
• 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: 04/22/2021
• Initial Report FDA Received Date: 05/20/2021
• 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