Portex 100/890/080CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15019315107177), received between Feb 4, 2019 and Apr 30, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Discolored” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2024Material Discolored; Defective Component; Material Discolored; Defective Component

  IT WAS REPORTED THAT THE INCIDENT OCCURRED WHEN AN INCORRECT INNER CANNULA CLEANING BRUSH WAS FOUND LODGED IN THE PATIENT¿S LEFT MAIN BRONCHUS AFTER AN EPISODE OF DESATURATION AND ACUTE RESPIRATORY DISTRESS. THERE WAS PATIENT INVOLVEMENT AND PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: Respiratory Insufficiency

  MAUDE report 19214312 ↗
• MalfunctionNov 6, 2020Material Discolored; Material Too Soft/Flexible; Material Discolored; Material Too Soft/Flexible

  IT WAS REPORTED THE DEVICE WAS IN USE WITH PATIENT AND WAS FOUND TO BE DISCOLORED AND SOFTER IN SOME AREAS. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10804940 ↗
• MalfunctionNov 6, 2020Material Discolored; Material Too Soft/Flexible; Material Discolored; Material Too Soft/Flexible

  IT WAS REPORTED THE DEVICE WAS IN USE WITH PATIENT AND WAS FOUND TO BE DISCOLORED AND SOFTER IN SOME AREAS. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10804908 ↗
• InjuryApr 18, 2019Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL REGARDING A PORTEX UNIPERC INNER CANNULAE. "WHEN ATTEMPTING TO INSERT NEW INNER TUBE IT ONLY WENT SO FAR THEN KINKED AT NECK OF INNER TUBE. CUSTOMER FELT LIKE THE MATERIAL WAS TOO SOFT AND KEPT BENDING. REPLACED IT WITH THE OLD INNER TUBE." NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8525680 ↗
• InjuryFeb 4, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED STATING TEMPORARY DIFFICULTY WITH VENTILATION THAT WAS PROMPTLY RESOLVED BY REPLACING THE INNER TUBE. IT WAS REPORTED THAT THERE WAS NO LASTING PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8302286 ↗