MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	100/897/080CZ
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	11/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Information received that the uniperc had cuff failure during an airway emergency.Tracheostomy tube was removed and the patient was intubated from above.No adverse effects.

• Brand Name: PORTEX UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• MDR Report Key: 11098423
• Report Number: 3012307300-2020-12882
• Device Sequence Number: 3755663
• Product Code: BTO
• UDI-Device Identifier: 15019315107207
• UDI-Public: 15019315107207
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 100/897/080CZ
• Device Catalogue Number: 100/897/080CZ
• Device Lot Number: 3986061
• 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: 11/30/2020
• Initial Report FDA Received Date: 12/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention