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

Model Number 6221

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

Event Date 01/25/2024

Event Type  malfunction  

Event 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
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): WESTMED, INC.; 5580 s. nogales highway; tucson AZ 85706
• MDR Report Key: 19213309
• MDR Text Key: 341391790
• Report Number: 19213309
• Device Sequence Number: 1
• Product Code: CAH
• UDI-Device Identifier: 00709078000959
• UDI-Public: (01)00709078000959
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 01/26/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2024
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Female