MAUDE Adverse Event Report: COVIDIEN SHILEY; TRACHEOSTOMY TUBE

Model Number 8DCT

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

It was reported that a tracheostomy tube was leaking air from the pilot balloon.This was discovered during patient use.The patient's mother taped the pilot balloon to prevent the cuff from leaking until a new product was received.There was no report of patient harm or injury.There is no report of serious injury or death associated with this event.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The sample was returned for investigation.The failure mode was not confirmed in the received sample.An inflation test was conducted and the cuff of the tube was still inflated after twenty four hours.The cuff deflated properly.All manufacturing controls were found effective to detect the reported failure mode.No fault was found with the returned sample.

• 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 ave; boulder, CO 80301 ; 3038768909
• MDR Report Key: 4477108
• MDR Text Key: 18634894
• Report Number: 2936999-2015-00097
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2015

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: Other
• Device Model Number: 8DCT
• Device Catalogue Number: 8DCT
• Device Lot Number: 14J0550JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2015
• Initial Date FDA Received: 02/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 77