MAUDE Adverse Event Report: Merit Maquiladora Mexico, S. DE R.L. DE C.V. Inflation Device.basixCOMPAK¿; SYRINGE, BALLOON INFLATION, EXEMPT

Catalog Number	IN4130/K
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2026
Type of Reportable Event	Malfunction

• Brand Name: Inflation Device.basixCOMPAK¿
• Common Device Name: SYRINGE, BALLOON INFLATION, EXEMPT
• Manufacturer (Section D): Merit Maquiladora Mexico, S. DE R.L. DE C.V.; avenida sor juana ines; 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; 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
• MDR Report Key: 50211800
• Report Number: 3011642792-2026-00137
• Device Sequence Number: 6122261
• Product Code: PTM
• UDI-Device Identifier: 00884450637524
• UDI-Public: 00884450637524
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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
• 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: 07/13/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown