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

Model Number	503080
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a smiths medical tracheostomy|pvc - portex tubes dic kept on popping out when inserted.No adverse effects were reported.

• Brand Name: PORTEX
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 10613327
• Report Number: 3012307300-2020-10012
• Device Sequence Number: 2719315
• Product Code: BTR
• UDI-Device Identifier: 10351688006677
• UDI-Public: 10351688006677
• Combination Product (Y/N): N
• 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): 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 503080
• Device Catalogue Number: 503080
• Device Lot Number: UNKNOWN
• 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: 09/17/2020
• Initial Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention