MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ULTRASET OXYGEN AND MEDICATION DELIVERY; CONNECTOR, AIRWAY (EXTENSION)

Model Number	66-2504
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Protocol number: no 510k number, 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 customer found the seal that holds the end-piece into place can be pulled off.No injury was reported.
Additional Manufacturer Narrative
Product was not returned, and no photographic evidence provided to aid in this investigation.As a result, product evaluation and problem confirmation cannot be performed.The root cause for this event is unknown.The product's history records were reviewed and there were no non-conformances that would have resulted in the reported complaint.For all enquiries or follow-up questions related to the record, do not use (b)(6)., please direct those to the following: (b)(6) full udi number:(b)(4).

• Brand Name: PORTEX ULTRASET OXYGEN AND MEDICATION DELIVERY
• 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: 16474075
• Report Number: 3012307300-2023-01959
• Device Sequence Number: 17438903
• 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): 07/08/2024

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
• 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: 06/20/2024
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 07/08/2024
• 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