MAUDE Adverse Event Report: COVIDIEN SILEY; TRACHEOSTOMY TUBES

Model Number 8LPC

Device Problems Air Leak (1008); Inflation Problem (1310)

Patient Problem Extubate (2402)

Event Date 01/05/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product was returned for investigation.An inflation and deflation test was performed.The failure mode was confirmed in the received sample.All manufacturing controls were found effective to detect the reported failure mode.A cut or tear of this magnitude at the time of manufacturing would have been detected during the inflate/deflate test and removed from the lot.The cut or tear condition found in the received sample is not confirmed as related to manufacturing process.

Event Description

It was reported that the tracheostomy tube was placed on (b)(6) 2014 in tracheostomy.The inflation pressure was 20-30 ml.The tube was checked before insertion.The lubricant used to place the tube is "silcospray" and they use "protonsan" or "betadine" to clean the stoma area.The inner cannula was cleaned using soap and water.Approximately one week later, on (b)(6) 2015, a leak in the luer valve was visually detected and so the cuff balloon deflated.So patient was placed a new tracheostomy tube and no further issues were noticed.There is no report of serious injury or death associated with this event.

Manufacturer Narrative

(b)(4).

• Brand Name: SILEY
• Type of Device: TRACHEOSTOMY TUBES
• 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: 4508961
• MDR Text Key: 13249229
• Report Number: 2936999-2015-00144
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K962173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/21/2015

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: 8LPC
• Device Catalogue Number: 8LPC
• Device Lot Number: 14A0727JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2015
• Initial Date FDA Received: 02/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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