MAUDE Adverse Event Report: PORTEX; TRACHEOSTOMY TUBE

Model Number	100/897/080CZ
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Ruptured cuff on posterior aspect.From mhra report: audible leak heard by staff nurse referred to ent following discussion with consultant ? cuff issue.No harm to patient.Scheduled tube change in theatre by ent surgeons.

• Brand Name: PORTEX
• Common Device Name: TRACHEOSTOMY TUBE
• MDR Report Key: 11670819
• Report Number: 3012307300-2021-03161
• Device Sequence Number: 3160874
• Product Code: BTO
• UDI-Device Identifier: 15019315107207
• UDI-Public: 15019315107207
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/15/2021

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: 12/10/2024
• Device Model Number: 100/897/080CZ
• Device Catalogue Number: 100/897/080CZ
• Device Lot Number: 3900085
• 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: 03/15/2021
• Initial Report FDA Received Date: 04/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2020
• 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: Initial
• Patient Sequence Number: 1