MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. BASIXCOMPAK¿; CATHETER-BALLOON INFLATOR, SINGLE-USE

Catalog Number	IN4130/K
Medical Device Problem Codes	Inflation Problem (1310); Detachment of Device or Device Component (2907); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
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
The account alleges that during the process of inflation, the handle was found to detach and became disconnected from the device.No patient injury.
Additional Manufacturer Narrative
The associated device was not returned to merit medical at the time of the evaluation, however, the customer did provide photo evidence of the handle and retaining cap removed from the syringe barrel.The complaint is confirmed and likely root cause is improper adhesive placement during assembly.A search of the complaint database was performed and one similar complaint for this lot number was found.The device history record was reviewed, and no exception documents were found.
Additional Manufacturer Narrative
The suspect device was returned for evaluation along with additional units from the same batch.The reported failure, plunger falls out of the inflation device, can be observed.The root cause can be attributed to improper placement of adhesive during assembly.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.

• Brand Name: BASIXCOMPAK¿
• Common Device Name: CATHETER-BALLOON INFLATOR, SINGLE-USE
• 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 ; 8012084225
• MDR Report Key: 23810607
• Report Number: 1721504-2025-00736
• Device Sequence Number: 21179520
• Product Code: PTM
• UDI-Device Identifier: 00884450637524
• UDI-Public: 00884450637524
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2026

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: 12/10/2025
• Supplement Date Received by Manufacturer: 01/13/2025; 05/06/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/14/2026; 05/06/2026
• 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