inforMED
MalfunctionCAF

HUDSON RCI

Received May 19, 2026 · Event occurred Apr 10, 2026

Report 1417592-2026-01481 · MDR key 25220153

Device

Generic name

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

Catalog number

HUD1734

Lot number

25IOA711

Product problems

  • Loose or Intermittent Connection

Patient

18 YR · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

PER REPORT, "THE OXYGEN SUPPLY LINE IS POPPING OFF FROM THE NEB CANISTER WITH APPROPRIATE OXYGEN FLOW RATES. I HAVE ATTACHED THE INSERT FROM THE KIT THAT THIS OCCURRED MOST RECENTLY. THERE WAS NO HARM TO THE PATIENT. WE WERE ABLE TO GET A DIFFERENT ONE AND HAD NO PROBLEM. I AM NOT SURE IF THE REPLACEMENT WAS THE SAME LOT OR NOT." CUSTOMER ALSO REPORTED THAT, "THE OXYGEN SUPPLY LINE IS POPPING OFF FROM THE NEB CANISTER WITH APPROPRIATE OXYGEN FLOW RATES." 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 REPORT, "THE OXYGEN SUPPLY LINE IS POPPING OFF FROM THE NEB CANISTER WITH APPROPRIATE OXYGEN FLOW RATES. I HAVE ATTACHED THE INSERT FROM THE KIT THAT THIS OCCURRED MOST RECENTLY. THERE WAS NO HARM TO THE PATIENT. WE WERE ABLE TO GET A DIFFERENT ONE AND HAD NO PROBLEM. I AM NOT SURE IF THE REPLACEMENT WAS THE SAME LOT OR NOT."