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

Model Number 66-2504

Device Problems Fitting Problem (2183); Connection Problem (2900)

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

Event Date 02/07/2023

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 310590571
• Report Number: 3012307300-2023-01958
• Device Sequence Number: 1
• Product Code: BZA
• UDI-Device Identifier: 10788942625044
• UDI-Public: 10788942625044
• 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,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1