MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO BASIXCOMPAK INFLATION DEVICE

Catalog Number	IN4802
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that the device did not keep pressure during the case.No patient injury reported.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device was examined visually and simulated use testing was performed.The complaint is confirmed.Root cause is attributed to the manufacturing process.A review of the device history record and the complaint database could not be performed as a lot number was not provided.

• Brand Name: BASIXCOMPAK INFLATION DEVICE
• Common Device Name: INFLATION DEVICE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 21976253
• Report Number: 3011642792-2025-00057
• Device Sequence Number: 9188231
• Product Code: PTM
• UDI-Device Identifier: 00884450638385
• UDI-Public: 00884450638385
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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 Catalogue Number: IN4802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown