inforMED
MalfunctionCAF

HUDSON RCI

Received Jul 2, 2026 · Event occurred Jun 5, 2026

Report 1417592-2026-03848 · MDR key 25692808

Device

Generic name

Nebulizer,updraft Ii,t,mouth,6",7'tub,uc

Catalog number

HUD1737

Lot number

2510A455

Product problems

  • Leak/Splash
  • Loose or Intermittent Connection

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

PER THE REPORT, "THEY ARE LEAKING AROUND THREADS WITHOUT BEING LOOSE AND THE TUBING POPS OFF CONSTANTLY ON 5 - 6 LPM." CUSTOMER ALSO REPORTED, "PATIENT SETUP USING UP-DRAFT II CIRCUIT, FLOW ON 6 LPM WITHIN 2 MINUTES TUBING POPPED OFF. PLACED TUBING BACK ON NEB CUP AND POPPED OFF AGAIN. REPLACED CIRCUIT TUBING WITH AN OXYGEN EXTENSION TUBING NO PROBLEMS FROM THERE." 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 MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

PER THE REPORT, "THEY ARE LEAKING AROUND THREADS WITHOUT BEING LOOSE AND THE TUBING POPS OFF CONSTANTLY ON 5 - 6 LPM."