MAUDE Adverse Event Report: COVIDIEN SHILEY; TRACHEOSTOMY TUBE

Model Number 6DCT

Device Problems Air Leak (1008); Tidal Volume Fluctuations (1634)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

Covidien reference number: (b)(4).Affected sample received 9/28/2015.Evaluation in process.

Event Description

It was reported that the cuff on a tracheostomy tube leaked in less than 48 hours.The leak was found when the patient's ventilator tidal volume was affected.An air leak could also be heard.The patient was recannulated and is tolerating well with no incident.

Manufacturer Narrative

(b)(4).One sample was received for evaluation.The cuff was observed to deflate within seconds during inflation/deflation testing.A visual analysis indicated that there were several small cuts observed on the cuff.The source of the cuts cannot be determined.A review of the manufacturing process and testing confirmed that there are several process steps that would detect holes or tears in the cuff prior to releasing the product for distribution.It is unknown how the cuff was tested by the customer prior to use.The instructions for use provide guidance on testing of the cuff prior to use including dimensional testing and the following caution: to ease insertion and to guard against cuff perforation from sharp edges of cartilage, the cuff should be tapered back.This can be accomplished by first inflating the cuff.Then gently move the cuff away from the distal tip of the outer cannula towards the swivel neck plate as the residual air is removed by deflation.Do not use any sharp instruments such as forceps of hemostats that would damage the cuff when tapering it.

• Brand Name: SHILEY
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): COVIDIEN; avenida henequen; 1181 parque industrial salvarcar; cd. juarez, chihuahua ; MX
• Manufacturer (Section G): COVIDIEN; avenida henequen; 1181 parque industrial salvarcar; cd. juarez, chihuahua ; MX
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5115790
• MDR Text Key: 27201475
• Report Number: 2936999-2015-00842
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/04/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 6DCT
• Device Catalogue Number: 6DCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR