Ciaglia Blue Rhino G2 G55651Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002556515), received between Aug 19, 2019 and Aug 19, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2019Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT THE DILATOR OF A CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET WITH VERSA TUBE PASSED OVER THE SAFETY RIDGE OF THE WHITE PRELOADED GUIDING CATHETER DURING A PERCUTANEOUS TRACHEOSTOMY PROCEDURE. IT WAS NOTED THAT THE, "TIP WAS VERY SOFT SO CURVED AND WENT TO MEDIASTINUM." IT WAS LATER REPORTED THAT NEITHER BRONCHOSCOPY OR OTHER IMAGING WERE USED DURING THE PROCEDURE. TO CONFIRM PLACEMENT OF THE NEEDLE IN THE TRACHEA, A SYRINGE WITH SALINE WAS CONNECTED TO THE NEEDLE, AND AS THE USER ASPIRATED, AIR WAS OBSERVED. THE WIRE WAS PLACED AND MAINTAINED WITHIN THE TRACHEA AS THE 14FR DILATOR WAS BEING INTRODUCED, AND A TWISTING MOTION WAS USED TO INSERT THE INTRODUCER. THE WIRE GUIDE WAS STILL PLACED IN THE TRACHEA WHEN THE 14FR DILATOR WAS REMOVED. EVEN WITH THE HYDROPHILIC COATING OF THE BLUE RHINO ACTIVATED, RESISTANCE WAS EXPERIENCED WHEN PLACING THE DEVICE. A "LITTLE" BLEEDING OCCURRED FROM THE PROCEDURE, HOWEVER, NO ADDITIONAL SURGICAL INTERVENTIONS WERE NEEDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 8908098 ↗
• MalfunctionAug 19, 2019Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT THE DILATOR OF THE CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET WITH VERSA TUBE PASSED THROUGH THE SAFETY RIDGE OF THE WHITE PRELOADING GUIDING CATHETER DURING A TRACHEOSTOMY PROCEDURE. IN THE USER'S OPINION THE, "RHINO DILATOR IS TOO SOFT." IT WAS LATER REPORTED THAT THE IFU WAS REFERENCED DURING THE PROCEDURE. A TWISTING MOTION WAS USED TO INSERT THE 14FR INTRODUCER, AND A LITTLE RESISTANCE WAS EXPERIENCED DURING PLACEMENT. THE HYDROPHILIC COATING WAS ACTIVATED ON THE BLUE RHINO. IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PROCEDURE WAS NOT PERFORMED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). IT WAS NOTED THAT THE PROCEDURE BEGAN WITH A PUNCTURE WITHOUT A SKIN INCISION AND NO PRE-TRACHEAL DISSECTION. A TOTAL OF SEVEN PUNCTURE ATTEMPTS WERE MADE. A FIBER SCOPE WAS ALSO NOT USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8907995 ↗