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

Catalog Number	IN4130/K
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow-up will be submitted when the evaluation is complete.
Event or Problem Description
A customer alleged a merit inflator handle disconnected at the screw thread.No reported patient injury.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The failure as reported was observed.The retainer cap and handle assembly had detached from the barrel of the device.The likely root cause can be attributed to operator error.Possibly, the operator did not follow the proper procedure to bond the retainer cap to the barrel of the device.A search of the complaint database was performed and one similar complaint for this lot number were found.The device history record was reviewed, and no exception documents were found.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be established.A search of the complaint database was performed and one similar complaints for this lot number was found.The device history record was reviewed, and no exception documents were found.

• 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: 23877224
• Report Number: 1721504-2025-00779
• Device Sequence Number: 4706769
• 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,Followup,Followup
• Report Date (Section B): 02/13/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 01/16/2026; 02/12/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/21/2026; 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown