MAUDE Adverse Event Report: MERIT MAQUILADORA MEXICO, S. DE R.L. DE C.V. BASIXCOMPAK¿; CATHETER-BALLOON INFLATOR, SINGLE-USE

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	04/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow-up will be submitted when new information becomes available.
Event or Problem Description
Customer reported when pressing the middle white swing arm upward, it detached from the middle transparent barrel.No patient harm.

• Brand Name: BASIXCOMPAK¿
• Common Device Name: CATHETER-BALLOON INFLATOR, SINGLE-USE
• Manufacturer (Section D): MERIT MAQUILADORA MEXICO, S. DE R.L. DE C.V.; avenida sor juana ines de la c; 19970 interior b, edificio 2; tijuana, baja california 22630 ; MX 22630
• Manufacturer (Section G): MERIT MAQUILADORA MEXICO, S. DE R.L. DE C.V.; avenida sor juana ines de la c; 19970 interior b, edificio 2; tijuana, baja california 22630 ; MX 22630
• Manufacturer Contact: lisa perz msn, rn, pmp ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 25623044
• Report Number: 3011642792-2026-00089
• Device Sequence Number: 18696440
• Product Code: PTM
• UDI-Device Identifier: 00884450637524
• UDI-Public: 00884450637524
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 06/30/2026

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: I3204117
• 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: 05/27/2026
• Supplement Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 06/25/2026
• Supplement Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown