MAUDE Adverse Event Report: PORTEX; TRACHEOSTOMY

Model Number	101/815/080
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical tracheostomy|pvc - portex tubes bluselect was found to be deviated downward and difficult to remove the inner cannula.This was observed with many trachs.

• Brand Name: PORTEX
• Common Device Name: TRACHEOSTOMY
• MDR Report Key: 12068181
• Report Number: 3012307300-2021-06548
• Device Sequence Number: 11615865
• Product Code: BTO
• UDI-Device Identifier: 15019517077360
• UDI-Public: 15019517077360
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2021

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: 101/815/080
• Device Catalogue Number: 101/815/080
• 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: 05/27/2021
• Initial Report FDA Received Date: 06/25/2021
• 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