MAUDE Adverse Event Report: COOK, INC. CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET W/SHILEY; KCG, DILATOR, TRACHEAL

Catalog Number C-PTIS-100-HC-PERC8

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem Ulcer (2274)

Event Type  Injury  

Event Description

A male pt developed necrotic pressure ulcer within 7 days of percutaneously placed shiley perc 8 tracheostomy tube.The shiley trach tube used is included in the blur rhino percutaneous tracheostomy introducer set.An ulcer was reported to the surgeon by the wound care nurse on site.The surgeon observed the ulcer and believes it was caused by the flange of the shiley trach tube pressing against the neck of the pt during a period of time when pt's head was propped up by pillows.The surgeon has begun placing a small pad underneath the flange of the trach tube after insertion and before suturing the trach tube in place as a possible solution.Previous 2 unreported events were similar in respect to the type of trach tube (shiley perc 8 trach tube included in blue rhino set) and the developement of a pressure ulcers beneath the flange.The pt did not require any additional procedures due to this occurrence.According to the initial reporter, the pt did not experience any adverse effects due tot his occurrence.No additional info has been provided by the reporter.

Manufacturer Narrative

Lot- unk as not provided by reporter.Expiration - unk as lot is unk.(b)(4).Event evaluation: still under investigation.

• Brand Name: CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET W/SHILEY
• Type of Device: KCG, DILATOR, TRACHEAL
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, dir ; 750 daniels way; bloomington, IN 47402 ; 8123392235
• MDR Report Key: 3767467
• MDR Text Key: 4486112
• Report Number: 1820334-2014-00156
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C-PTIS-100-HC-PERC8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 03/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other