MAUDE Adverse Event Report: COVIDIEN SHILEY; DISP.CAN. P-C 8-12.0 BX1

Model Number 8DCT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Dyspnea (1816)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the tracheostomy tube pilot balloon would not hold cuff pressure so they could not ventilate the patient.There was increased work of breathing and shortness of breath.After the tube was changed the patient went back to baseline with no more respiratory distress.

Manufacturer Narrative

(b)(4).One sample was received for evaluation.Functional test of inflation and deflation tests were performed and it was observed that there was a leak in the cuff.The sample was observed under uv light looking for bonding agent (mek) and it was observed the bonding agent was not applied evenly, causing the cuff separation from the cannula, thus leaking the air.The reported complaint is confirmed.The complaint was confirmed.

• Brand Name: SHILEY
• Type of Device: DISP.CAN. P-C 8-12.0 BX1
• 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: ray maroofian ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035334
• MDR Report Key: 6281651
• MDR Text Key: 65900918
• Report Number: 2936999-2017-00071
• 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: consumer,health professional
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8DCT
• Device Catalogue Number: 8DCT
• Device Lot Number: 16E0665JZX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 143