MAUDE Adverse Event Report: WESTMED, INC. FILTER; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number	6221
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
One of the reinforced staple loads reinforcement was not attached and flopping all around.It wouldn't sit well when attempted to use by not lining up correctly on staple load so it wasn't used.Removed from field and another one was opened and used instead.Removed from field and given to management.No patient harm.

• Brand Name: FILTER
• Common Device Name: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): WESTMED, INC.; 5580 s. nogales highway; tucson AZ 85706
• MDR Report Key: 19213309
• Report Number: 19213309
• Device Sequence Number: 8198748
• Product Code: CAH
• UDI-Device Identifier: 00709078000959
• UDI-Public: (01)00709078000959
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/26/2024
• Report Date (Section F): 01/26/2024

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: 6221
• Device Lot Number: N3K2598Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/26/2024