MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; INNER CANNULA

Model Number	100/856/090
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the label for inner cannula shows id is 9.0 mm but also shows id is 8.0 mm.No patient involvement.

• Brand Name: PORTEX
• Common Device Name: INNER CANNULA
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 11280134
• Report Number: 3012307300-2021-00853
• Device Sequence Number: 11797301
• Product Code: BTO
• UDI-Device Identifier: 15019315052644
• UDI-Public: 15019315052644
• Combination Product (Y/N): N
• PMA/510(K) Number: K030381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2021

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?: No
• Operator of Device: No Information
• Device Model Number: 100/856/090
• Device Catalogue Number: 100/856/090
• Device Lot Number: 3921292
• 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: 01/08/2021
• Initial Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1