MAUDE Adverse Event Report: ST PAUL PORTEX; TRACHEAL TUBE

Model Number	100/166/070
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a smiths medical trach was unable to be inflated at the cuff during a pre-use check.In addition, the shape of the inflated was different from usual.There was no patient injury.

• Brand Name: PORTEX
• Common Device Name: TRACHEAL TUBE
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11039799
• Report Number: 3012307300-2020-12557
• Device Sequence Number: 13709105
• Product Code: BTR
• UDI-Device Identifier: 15019315054082
• UDI-Public: 15019315054082
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/18/2020

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 Model Number: 100/166/070
• Device Lot Number: 3962908
• 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: 11/24/2020
• Initial Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1