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

Model Number	100/890/080CZ
Medical Device Problem Codes	Material Discolored (1170); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device was in use with patient and was found to be discolored and softer in some areas.No adverse effects reported.

• Brand Name: PORTEX INNER CANNULA
• 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: 10804908
• Report Number: 3012307300-2020-11149
• Device Sequence Number: 3569469
• 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: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/06/2020

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: 10/31/2020
• Device Model Number: 100/890/080CZ
• Device Catalogue Number: 100/890/080CZ
• Device Lot Number: 3075641
• 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: 10/08/2020
• Initial Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1