PORTEX OXYGEN/AEROSOL TUBING
Received Jul 7, 2026 · Event occurred Jun 1, 2026
Report 3012307300-2026-07082 · MDR key 25736171
Device
Generic name
Aerosol Delivery Tubing
Manufacturer
Icu Medical, Inc.Catalog number
20701
Lot number
6096565
Product problems
- Fluid/Blood Leak
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PRODUCT QUALITY ISSUE IN WHICH MEDICATION ESCAPED FROM THE LEFT SIDE OF THE CHAMBER DURING USE DESPITE FOLLOWING THE INSTRUCTIONS FOR USE. NO VISIBLE CRACKS OR DAMAGE WERE OBSERVED. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO PATIENT HARM WAS REPORTED.
Additional Manufacturer Narrative
B3 ¿ THE DATE OF THE EVENT IS UNKNOWN; THEREFORE, THE EVENT DATE WILL BE RECORDED AS THE FIRST DAY OF ICU AWARE DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.