MAUDE Adverse Event Report: PORTEX; CONNECTOR, AIRWAY (EXTENSION)

Model Number	66-1991
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon used a swivel adaptor.Device malfunctioned, was replaced with a second identical swivel adaptor.Second device also malfunctioned.

• Brand Name: PORTEX
• Common Device Name: CONNECTOR, AIRWAY (EXTENSION)
• MDR Report Key: 10800971
• Report Number: 10800971
• Device Sequence Number: 3267140
• Product Code: BZA
• UDI-Device Identifier: 10788942619913
• UDI-Public: (01)10788942619913(11)190729(10)3849847
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/20/2020
• Report Date (Section F): 10/20/2020

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: Health Professional
• Device Model Number: 66-1991
• Device Lot Number: 3849847
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/06/2020
• Initial Date Received by Manufacturer: Not provided
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/20/2020