PORTEX BLUSELECT SUCTIONAID TRACHEOSTOMY TUBE
Received Feb 25, 2025 · Event occurred Dec 23, 2024
Report 3011237704-2025-00032 · MDR key 21463847
Device
Generic name
Bag, Reservoir
Manufacturer
Smiths Medical Czech Republic A. SCatalog number
101/870/070CZ
Lot number
UNKNOWN
Product problems
- Crack
- Connection Problem
- Crack
- Connection Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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.
Description of Event or Problem
IT WAS REPORTED THAT THE CONNECTION PART ON SUCTION LINE CRACKED. THERE WERE UNKNOW PATIENT HARM OR ADVERSE EVENT REPORTED AS A RESULT OF THE EVENT.
Additional Manufacturer Narrative
THIS COMPLAINT WAS INCORRECTLY FILED UNDER THIS REGISTRATION NUMBER, PLEASE REFERENCE MRN 3012307300-2025-05172-00 FOR DETAILS PERTINENT TO THIS EVENT.