inforMED
InjuryBSY

BALLARD SUCTION CATHETERS

Received Apr 30, 2025 · Event occurred Apr 18, 2025

Report MW5169668 · MDR key 21935925

Device

Generic name

Catheters, Suction, Tracheobronchial

Catalog number

20083

Lot number

1555215

Product problems

  • Nonstandard Device

Patient

22 MO · Male

  • Pneumonia
  • Pneumonia

Narrative

Description of Event or Problem

PATIENT USES THE BALLARD 8 FR SUCTION CATHETERS, WHICH WERE RECENTLY RECALLED FOR BEING NON-STERILE. IN THE LAST WEEK, PATIENT EXPERIENCED SYMPTOMS OF PNEUMONIA. CAREGIVERS BELIEVE THIS COULD HAVE BEEN CAUSED BY THE USE OF THE NON-STERILE SUCTION CATHETERS. THE SYMPTOMS HAVE SINCE SUBSIDED. UPON FURTHER INVESTIGATION, THE PATIENT HAD THE RECALLED PRODUCT IN THE HOME.