MAUDE Adverse Event Report: COVIDIEN SHILEY; TRACHEOSTOMY TUBE

Model Number 18870

Device Problems Deflation Problem (1149); Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2014

Event Type  Injury  

Event Description

The customer reports that the device was checked before use but once fitted, the cuff deflated straight away and a hole was noticed.The patient desaturated at 38% and had to be re-intubated with a new device.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.An inflation deflation test was performed.When air was applied, the cuff was found to deflate immediately.A visual inspection was performed and found a cut in the cuff.The manufacturing guidelines and controls were reviewed and found acceptable and effective, to detect the reported event.A cut of this magnitude at the time of manufacturing would have been detected during the inflate deflate testing and removed from the lot.The cut condition found in the received sample is not related to the manufacturing process.

• 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: 4418800
• MDR Text Key: 5373857
• Report Number: 2936999-2015-00035
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 18870
• Device Catalogue Number: 18870
• Device Lot Number: UKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2015
• 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