MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. ALL BRASS REGULATOR; REGULATOR, PRESSURE, GAS CYLINDER

Model Number	L280-220K
Medical Device Problem Codes	Gas/Air Leak (2946); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown, no information has been provided to date.G5: device code is 510k 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 product is bent and has a leak.There was no patient involvement.No harm reported.
Additional Manufacturer Narrative
One device was received for investigation.During visual inspection the device was observed to have its coupler and gauge deformed.The reported issue was confirmed during functional testing, when the device was observed to be leaking.The investigation attributed the observed condition to user interface.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.The device pressure gauge and coupler were replaced.

• Brand Name: ALL BRASS REGULATOR
• Common Device Name: REGULATOR, PRESSURE, GAS CYLINDER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18432386
• Report Number: 3012307300-2024-00016
• Device Sequence Number: 6950019
• Product Code: CAN
• UDI-Device Identifier: 00026072021989
• UDI-Public: (01)00026072021989(11)190208
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2024

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: Other
• Device Model Number: L280-220K
• Device Catalogue Number: L280-220KJP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 02/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2019
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown