MAUDE Adverse Event Report: COVIDIEN SHILEY; TRACEOSTOMY TUBES

Model Number 8SCT

Device Problems No Pressure (2994); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2014

Event Type  Injury  

Event Description

It was reported that shortly after intubation, the cuff pressure declined when the air was inserted into it.There is no report of serious injury or death associated with this event.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The tracheostomy tube, single cannula, was received for evaluation.A visual inspection was performed, and it was observed that all components were assembled properly in the tube, according to drawings.Performance tests of inflation and deflation were performed, and it was observed that the unit held the air.The sample was left inflated 24hours, according to process instructions, and no deflation was observed after this time.No failure mode was observed in the device, and the customer reported malfunction was not verified.

• Brand Name: SHILEY
• Type of Device: TRACEOSTOMY 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: denise braxton ; 6135 gunbarrel ave; boulder, CO 80301 ; 3038768909
• MDR Report Key: 4326307
• MDR Text Key: 5245752
• Report Number: 2936999-2014-01059
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K962173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2014

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: 8SCT
• Device Catalogue Number: 8SCT
• Device Lot Number: 1310193JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2015
• Initial Date FDA Received: 12/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/22/2015
• 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