MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TRACHEOSTOMY TUBE

Model Number	100/110/080
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During a pre-use check, the customer noticed air was leaking from the cuff.No patient injury.
Additional Manufacturer Narrative
Returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.Problem source was traced to manufacturing.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: PORTEX
• Common Device Name: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 11116646
• Report Number: 3012307300-2021-00057
• Device Sequence Number: 3595562
• Product Code: BTR
• UDI-Device Identifier: 15019315050800
• UDI-Public: 15019315050800
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2021

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: 04/01/2025
• Device Model Number: 100/110/080
• Device Catalogue Number: 100/110/080
• Device Lot Number: 3952585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 03/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1