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 Codes	Hypoventilation (1916); No Code Available (3191)
Date of Event	01/08/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
The complainant reported that a percutaneous tracheostomy was performed using a ciaglia blue rhino percutaneous tracheostomy introducer set with versa tube and the patient could not be ventilated.The inner woerther tube couldn't be blocked because the cannula had a hole.The patient required an additional procedure to remove the cannula and place a new device.There were no additional adverse effects to the patient reported.

• 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: 7373585
• Report Number: 1820334-2018-00854
• Device Sequence Number: 1147042
• 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: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: G55652
• Device Catalogue Number: C-PTIS-350-HC-G-VT9
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention