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

Catalog Number	IN4130/K
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The failure as reported was observed.The retainer cap and handle assembly returned loose from the barrel of the device.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and two similar complaints for this lot number was identified.
Event or Problem Description
A customer alleged during use, the inflation syringe unscrews.No reported patient injury.

• Brand Name: INFLATION DEVICE.BASIXCOMPAK¿
• Common Device Name: SYRINGE, BALLOON INFLATION, EXEMPT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 24550722
• Report Number: 1721504-2026-00903
• Device Sequence Number: 13107990
• Product Code: PTM
• UDI-Device Identifier: 00884450637524
• UDI-Public: 00884450637524
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2026

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
• Device Catalogue Number: IN4130/K
• Device Lot Number: I3204122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown