MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX®UNIPERC® ADJUSTABLE FLANGE EXTENDED-LEGNTH PERCUTANOUS KIT AND TRACH TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	100/890/080CZ
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received while a smiths medical tracheostomy was in use, resistance was encountered with the cannula.This resulted in distortion of the cannula and difficulty ventilating the patient.Upon removal, narrowing of the lumen occurred.
Additional Manufacturer Narrative
Incorrect aware date: 12/19/2019.Correct aware date: 12/24/2019.
Event or Problem Description
Additional information received stating temporary difficulty with ventilation that was promptly resolved by replacing the inner tube.It was reported that there was no lasting patient harm.

• Brand Name: PORTEX®UNIPERC® ADJUSTABLE FLANGE EXTENDED-LEGNTH PERCUTANOUS KIT AND TRACH TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8302286
• Report Number: 3012307300-2019-00545
• Device Sequence Number: 19244936
• Product Code: BTO
• UDI-Device Identifier: 15019315107177
• UDI-Public: 15019315107177
• 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: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2019

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?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 100/890/080CZ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 02/06/2019; 01/14/2019
• Initial Report FDA Received Date: 02/04/2019
• Supplement Report FDA Received Date: 04/09/2019; 07/26/2019
• 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