inforMED
MalfunctionBTA

MEDLINE

Received Jun 22, 2026 · Event occurred May 22, 2026

Report 1417592-2026-02914 · MDR key 25585987

Device

Generic name

Aspirator,suction,w/850cc Canister

Catalog number

HCS7001

Lot number

6462508

Product problems

  • Fluid/Blood Leak
  • Suction Problem

Patient

NA · Female

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

IT WAS REPORTED THAT FLUIDS WERE SUCKED INTO THE SYSTEM AND ARE LEAKING FROM THE DEVICE. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.

Description of Event or Problem

IT WAS REPORTED THAT FLUIDS WERE SUCKED INTO THE SYSTEM AND ARE LEAKING FROM THE DEVICE.