MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX; CONNECTOR, AIRWAY (EXTENSION)

Model Number	66-1991
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name is unknown; no additional information was received.No product was returned, thus the failure mode reported was not confirmed and a root cause could not be determined.There was one sample remaining in stock from the lot number reported on this complaint.The sample was evaluated and tested per internal procedures.There were no visual defects identified.The sample passed the leak test and the pull test per the internal test procedures.The manufacturer purchases this device from a supplier.There are two supplier non-conformances recorded.One was recorded in (b)(6) 2018 due to a documentation error, ports' undersized dimensions, and the device failing the leak and pull tests.Using the risk matrix, this non-conformance was determined to be a very low overall risk.The second supplier non-conformance was recorded in (b)(6) 2020 due to the slits in the port not open.The supplier put in place a corrective action implementing a second poka-yoke to use during the in-process inspection to confirm the cut is present before devices are packaged.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that, during use by the surgeon, the swivel adaptor malfunctioned.It was replaced with a second identical swivel adaptor.No patient injury was reported.

• Brand Name: PORTEX
• Common Device Name: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15414333
• Report Number: 3012307300-2022-19005
• Device Sequence Number: 14862966
• Product Code: BZA
• UDI-Device Identifier: 10788942619913
• UDI-Public: 10788942619913
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2022

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 Expiration Date: 07/30/2024
• Device Model Number: 66-1991
• Device Catalogue Number: 66-1991
• Device Lot Number: 3849847
• 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: 07/07/2022
• Initial Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown