MalfunctionPTM
BASIXCOMPAK¿
Received Jun 26, 2026 · Event occurred May 6, 2026
Report 3011642792-2026-00085 · MDR key 25635651
Device
Generic name
Syringe, Balloon Inflation, Exempt
Manufacturer
Merit Maquiladora Mexico, S. De R.l. De C.v.Catalog number
IN4130/K
Lot number
I3204117
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT WHEN TRYING TO INFLATE TO THE WHITE ROTATING ARM IN THE MIDDLE, IT GOT DETACHED FROM THE TRANSPARENT BODY. NO PATIENT HARM.
Additional Manufacturer Narrative
THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A FOLLOW-UP WILL BE SUBMITTED WHEN NEW INFORMATION BECOMES AVAILABLE.