MalfunctionPTM
BASIXCOMPAK¿
Received Jun 25, 2026 · Event occurred Apr 29, 2026
Report 3011642792-2026-00089 · MDR key 25623044
Device
Generic name
Catheter-balloon Inflator, Single-use
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
Additional Manufacturer Narrative
THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. A FOLLOW-UP WILL BE SUBMITTED WHEN NEW INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
CUSTOMER REPORTED WHEN PRESSING THE MIDDLE WHITE SWING ARM UPWARD, IT DETACHED FROM THE MIDDLE TRANSPARENT BARREL. NO PATIENT HARM.