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

Model Number	66-2509
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event and 510k are unknown; no information has been provided to date.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 device was connected to an anesthesia patient circuit and a leak was noticed on the port.It was also mentioned that there was a melted hole on the swivel adaptor.There was no harm or delay in therapy to the patient since the issue was caught immediately and the set changed.
Additional Manufacturer Narrative
Other, other text: additional information is provided in h.2., and h.6.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 regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.D.4.Full udi number: (b)(4).

• 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: 16432684
• Report Number: 3012307300-2023-01592
• Device Sequence Number: 14805401
• Product Code: BZA
• UDI-Device Identifier: 10788942625099
• UDI-Public: 10788942625099
• 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): 08/13/2024

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: 66-2509
• Device Catalogue Number: 66-2509
• Device Lot Number: 4298272
• 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: 02/01/2023
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2022
• 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