MAUDE Adverse Event Report: COVIDIEN SHILEY; TRACHEOSTOMY TUBE

Model Number 18880

Device Problem Air Leak (1008)

Patient Problem Extubate (2402)

Event Date 01/28/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The referenced tracheostomy tube was reported to have a "cuff won't inflate" issue.The referenced device was received for further evaluation.An inflation/deflation test was performed using a syringe.The tube's cuff was inflated with 25cc's of air.The cuff was observed to immediately deflate.Visual inspection of the device showed two small tears on the cuff.The reported event was confirmed.No lot number was provided to conduct a device history review (dhr) however a review of manufacturing process and work instructions the following facts were concluded: all manufacturing controls were found acceptable and effective to detect the reported failure mode.Inflation tests are performed for all taperguard products.The operator inspects all products for no leaks and segregates the defective parts.All taperguard products have a resting time of two hours.Deflation tests are also performed for all taperguard products.The operator again inspects for no leaks and segregates the defective parts.Once the parts are visually inspected, all cuffs are deflated.Tears of this magnitude, at the time of manufacturing, would have been detected during the 100% inflate/deflate test and removed from the lot.The tear condition found in the received sample was not confirmed as related to manufacturing process.

Event Description

A report was received stating one day following intubation a tracheostomy tube's cuff experienced a leak.Recannulation of the patient was required.The cuff was found to have passed 'prior to use' testing.There was no harm to the patient reported.There was no serious injury or death associated with this event.

Manufacturer Narrative

(b)(4).The lot number for the referenced device was not provided therefore a device history review cannot be performed.

• 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: denise braxton ; 6135 gunbarrel avenue; boulder, CO 80301 ; 3038768909
• MDR Report Key: 4481323
• MDR Text Key: 13209167
• Report Number: 2936999-2015-00102
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K090352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2015

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: 18880
• Device Catalogue Number: 18880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2015
• Initial Date FDA Received: 02/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/07/2015
• 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