MAUDE Adverse Event Report: PORTEX; TRACHEOSTOMY TUBE

Model Number	100/541/080CZ
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient experienced discomfort after trach tube was inserted.Concerns on which size inner cannula is needed.No adverse patient effects were reported.

• Brand Name: PORTEX
• Common Device Name: TRACHEOSTOMY TUBE
• MDR Report Key: 11580284
• Report Number: 3012307300-2021-02570
• Device Sequence Number: 11953771
• Product Code: BTO
• UDI-Device Identifier: 15019315106606
• UDI-Public: 15019315106606
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K060945
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2021

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: 100/541/080CZ
• Device Catalogue Number: 100/541/080CZ
• 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: 02/26/2021
• Initial Report FDA Received Date: 03/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1