MAUDE Adverse Event Report: MERIT MAQUILADORA MEXICO, S. DE R.L. DE C.V. BASIXCOMPAK¿; SYRINGE, BALLOON INFLATION, EXEMPT

Catalog Number	IN4330
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The handle detached during use on a patient.No patient injury or medical intervention was reported.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The investigation identified that adhesive had not been applied to the unit.The complaint could be confirmed.The root cause can be attributed to improper method used during assembly a search of the complaint database was performed and no similar complaints 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: 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, 22630 ,; MX 22630,
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84905 ; 8012084225
• MDR Report Key: 25176243
• Report Number: 3011642792-2026-00080
• Device Sequence Number: 21488735
• Product Code: PTM
• UDI-Device Identifier: 00884450638323
• UDI-Public: 00884450638323
• 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): 05/14/2026

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: IN4330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown