PORTEX TUBES BLUSELECT SUCTIONAID
Received Feb 18, 2026 · Event occurred Jan 1, 2026
Report 3012307300-2026-01426 · MDR key 24378931
Device
Generic name
Bag, Reservoir
Catalog number
101/870/070
Lot number
6108722
Product problems
- Crack
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILLED 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 PATIENT CAME IN FOR A TRACHY CHANGE AND NOTED A HAIRLINE CRACK IN THE IN-LINE SUCTION AID TIP WHEN SYRINGE WAS INSERTED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.
Additional Manufacturer Narrative
THE SUSPECTED DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND THERE WAS A SMALL HAIRLINE CRACK ON THE SUCTION VALVE. A FUNCTIONAL TEST WAS PERFORMED AND THE REPORTED ISSUE WAS CONFIRMED. THE CAUSE OF THE REPORTED ISSUE WAS UNKNOWN. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE.