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

Model Number 66-2509

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 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.

• Brand Name: PORTEX OXYGEN/AEROSOL ADAPTERS AND CONNECTORS
• Type of Device: 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: 16432684
• MDR Text Key: 310156062
• Report Number: 3012307300-2023-01592
• Device Sequence Number: 1
• Product Code: BZA
• UDI-Device Identifier: 10788942625099
• UDI-Public: 10788942625099
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 66-2509
• Device Catalogue Number: 66-2509
• Device Lot Number: 4298272
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1