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

Model Number	100/897/080
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that the locking mechanism to a smiths medical portex® uniperc® adjustable flange tracheostomy tube was noted to malfunction; leaving the tube susceptible to being displaced.It was reported that the tube slide in and out while the patient was being mechanically ventilated.Subsequently, the tube was immediately replaced.There were no reported adverse effects.

• Brand Name: PORTEX® UNIPERC® ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 9753993
• Report Number: 3012307300-2020-01517
• Device Sequence Number: 17002235
• Product Code: BTO
• UDI-Device Identifier: 15019315060441
• UDI-Public: 15019315060441
• 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): 02/25/2020

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?: Yes
• Operator of Device: No Information
• Device Model Number: 100/897/080
• Device Catalogue Number: 100/897/080
• Device Lot Number: 3645624
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/26/2020
• 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