MAUDE Adverse Event Report: PORTEX; TRACHEOSTOMY

Model Number	8.0MM
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	02/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Information received a smiths medical tracheostomy|pvc - portex tubes pdt uniperc was leaking from the channel by pilot balloon and cuff.Weak occurred during patient usage as tidal volumes was not being achieved.Ent was consulted and urgent assessment was made for tracheotomy tube exchange size 8 was exchanged and cuff pressure checked with no leak.

• Brand Name: PORTEX
• Common Device Name: TRACHEOSTOMY
• MDR Report Key: 11646672
• Report Number: 3012307300-2021-03044
• Device Sequence Number: 2899789
• 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
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2021

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: 06/23/2025
• Device Model Number: 8.0MM
• Device Catalogue Number: 100/897/080CZ
• Device Lot Number: 3986057
• 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: 03/12/2021
• Initial Report FDA Received Date: 04/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2020
• 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