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

Model Number	100/870/080
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The day of the event date is unknown.Only the month (b)(6) and year (2020) are known.Customer facility phone number: (b)(6).Company representative phone number: (b)(6).
Event or Problem Description
It was reported that the cuff component of the blue line ultra (blu) tracheostomy tube was deflating too easily.No patient injury or complications were reported in relation to this event.

• Brand Name: PORTEX
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL, ASD INC.; 6000 nathan lane; minneapolis, mn
• MDR Report Key: 10461508
• Report Number: 3012307300-2020-06859
• Device Sequence Number: 19369906
• Product Code: BTO
• UDI-Device Identifier: 15019315038808
• UDI-Public: 15019315038808
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/27/2020

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: 01/17/2025
• Device Model Number: 100/870/080
• Device Catalogue Number: 100/870/080
• Device Lot Number: 3913697
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1