MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX OXYGEN/AEROSOL ADAPTERS AND CONNECTORS; CONNECTOR, AIRWAY (EXTENSION)

Model Number	66-2504
Medical Device Problem Codes	Fitting Problem (2183); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Protocol number is blank as device is exempt.Investigation, including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the seal that holds the one end piece into place can be pulled off.The given part number was (b)(4).There has been no report of observable clinical symptoms or a change in symptoms identified in the patient as this was found in pre-test.
Additional Manufacturer Narrative
Device evaluated by manufacturer and health impact, event problem and evaluation codes: updated.Device evaluation: one (1) device was received.Upon visual inspection the device looked properly assembled.Unit not missing heat stakes fitting look properly attached.Proceeded with pull test and failed.Connector separated from assembly confirming the complaint.Failure may have occurred during manufacturing assembly at one (1) heat stake affixing 15mm connector to 15mm flex tube because heat stake did not fully penetrate tubing into fitting.A device history record (dhr) review showed no reported discrepancies during the manufacturing of the reported lot number.No action taken.

• Brand Name: PORTEX OXYGEN/AEROSOL ADAPTERS AND CONNECTORS
• Common Device Name: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16473675
• Report Number: 3012307300-2023-01958
• Device Sequence Number: 20727724
• Product Code: BZA
• UDI-Device Identifier: 10788942625044
• UDI-Public: 10788942625044
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 03/28/2023

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: 66-2504
• Device Catalogue Number: 66-2504
• Device Lot Number: 4348682
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/21/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown