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Ciaglia Blue Rhino G13166Recalls & reported problems

Cook Incorporated · Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Tray · Class 2

All models of Ciaglia Blue Rhino (7)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002131668), received between Sep 25, 2018 and Sep 25, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

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

Device problems

  • Device Contamination with Chemical or Other Material1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 25, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED A CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY WITH SHILEY WAS MISSING A COMPONENT. DURING INVESTIGATION, AN UNUSED/SEALED DEVICE WAS RETURNED FOR EVALUATION. FOREIGN MATTER WAS FOUND WITHIN THE SEALED STERILE TRAY.

    Patient problems: No Patient Involvement

    MAUDE report 7906185 ↗

Other Tube tracheostomy and tube cuff devices

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Sources and updates

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