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

Model Number	G12523
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/25/2015
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
The complainant reported the following information in a voluntary medwatch: during a percutaneous tracheostomy, a cook ciaglia blue rhino percutaneous size 8 tracheostomy tube was inserted into the patient's trachea.The ventilator was connected to the tracheostomy tube.However there was difficulty ventilating the patient.It was noted that the balloon was not staying inflated.Therefore the bronchoscope was reinserted.The guidewire unit was reinserted through the tracheostomy tube.The tracheostomy tube was removed and a new tracheostomy tube (shiley size 8 cuffed tracheostomy tube) was inserted.The balloon was insufflated and it remained insufflated.The ventilator was connected at that time and patient was successfully ventilated.

• Brand Name: CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET WITH SHILEY
• Common Device Name: JOH TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7376780
• Report Number: 1820334-2018-00890
• Device Sequence Number: 1094989
• Product Code: JOH
• UDI-Device Identifier: 00827002125230
• UDI-Public: (01)00827002125230(17)170917(10)5281744
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• 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: G12523
• Device Catalogue Number: C-PTIS-100-HC-PERC8
• 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
• Patient Age: 58 YR
• Patient Weight: 54