InjuryBSY
BALLARD SUCTION CATHETERS
Received Apr 30, 2025 · Event occurred Apr 18, 2025
Report MW5169668 · MDR key 21935925
Device
Generic name
Catheters, Suction, Tracheobronchial
Manufacturer
Sunmed Group Holdings, Llc Dba AirlifeCatalog 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.