MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. BASIXTOUCH¿ INFLATION DEVICE; SYRINGE, BALLOON INFLATION, EXEMPT

Catalog Number	IN8130/C
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges a piece of the plastic was broken off and therefore sterile barrier is compromised.No additional patient consequence to report.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint cannot be confirmed and a root cause cannot be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: BASIXTOUCH¿ INFLATION DEVICE
• Common Device Name: SYRINGE, BALLOON INFLATION, EXEMPT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 22523252
• Report Number: 1721504-2025-00153
• Device Sequence Number: 7951021
• Product Code: PTM
• UDI-Device Identifier: 00884450621059
• UDI-Public: 00884450621059
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: IN8130/C
• Device Lot Number: H3141564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown