MAUDE Adverse Event Report: COVIDIEN SHILEY; PHONATE VALVE W/OXIGEN PRT BX1

Model Number SSVO

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer did not retain the lot number which determines the date of manufacture.

Event Description

The customer reported that the blue plug on the speaking valve fell off and in some way ended in the patient's tracheostomy / lungs.The patient was able to cough it up without any intervention from the hospital staff.It was unknown how long it had been there.The patient was already receiving treatment for pneumonia at the time of the incident and the antibiotic treatment was not changed.The patient suffered no further deterioration as a result of the incident.

• Brand Name: SHILEY
• Type of Device: PHONATE VALVE W/OXIGEN PRT BX1
• Manufacturer (Section D): COVIDIEN; via bove, 2; i-41037; mirandola ; IT
• Manufacturer (Section G): COVIDIEN; via bove, 2; i-41037; mirandola ; IT
• Manufacturer Contact: ray maroofian ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035334
• MDR Report Key: 6237048
• MDR Text Key: 64714430
• Report Number: 2936999-2017-00029
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K945406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2016
• Initial Date FDA Received: 01/10/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 54