MAUDE Adverse Event Report: COOK INC CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET WITH VERSA TUBE; JOH TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	G55652
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
It was reported that after the ciaglia blue rhino percutaneous tracheostomy introducer set with versa tube was placed, it would not properly ventilate due to a cuff leak.Another cannula was placed to complete the procedure, and there were no injuries or additional procedures.

• Brand Name: CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET WITH VERSA TUBE
• Common Device Name: JOH TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7378034
• Report Number: 1820334-2018-00882
• Device Sequence Number: 16392120
• Product Code: JOH
• UDI-Device Identifier: 00827002556522
• UDI-Public: (01)00827002556522(17)170717(10)5159896
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G55652
• Device Catalogue Number: C-PTIS-350-HC-G-VT9
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1