MAUDE Adverse Event Report: COVIDIEN SHILEY; SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT

Model Number SSVO

Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395)

Patient Problem Respiratory Distress (2045)

Event Date 09/17/2015

Event Type  Injury  

Manufacturer Narrative

Covidien reference number: (b)(4).

Event Description

It was reported that the blue plug on the o2 connector on the phonate valve (ssvo) came off and wandered into the patient's cannula.The patient experienced respiratory problems ("nearly suffocated"), but the problem was instantly discovered and the blue plug was removed very quickly from the airway.

• Brand Name: SHILEY
• Type of Device: SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT
• Manufacturer (Section D): COVIDIEN; via bove, 2; i-41037; mirandola ; IT
• Manufacturer (Section G): COVIDIEN; via bove, 2; i-41037; mirandola ; IT
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5154604
• MDR Text Key: 28449564
• Report Number: 2936999-2015-00882
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K945407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 09/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SSVO
• Device Catalogue Number: SSVO
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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