MalfunctionCAI
PORTEX ANESTHESIA BREATHING CIRCUIT
Received Jul 13, 2026 · Event occurred Jan 1, 2025
Report 3012307300-2026-07367 · MDR key 25802585
Device
Generic name
Circuit, Breathing (w Connector, Adaptor, Y Piece)
Catalog number
C45101340-NLJ
Lot number
6009286
Product problems
- Gas/Air Leak
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A LEAK ALARM WAS DETECTED DURING PRE-USE CHECK. THERE WAS NO PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.
Additional Manufacturer Narrative
ONE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED, DURING WHICH A CUT/TEAR WAS OBSERVED ON THE BAG. THE ISSUE REPORTED BY THE COMPLAINANT WAS CONFIRMED. THE PROBABLE CAUSE OF THE TEAR IS UNKNOWN.