MAUDE Adverse Event Report: COVIDIEN SHILEY; SPEAKING VALVE

Model Number SSV

Device Problems Inadequacy of Device Shape and/or Size (1583); Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This complaint was reviewed by the clinical team and found to be non-reportable, as the event does not match the requirements for emdr reportability.Please disregard report # 2936999-2014-00903, submitted in error.

Event Description

It was reported by a customer in the usa, that the ssv phonate speaking valve did not fit, as it had a different length and diameter than the ssv's previously used.The issue was observed during inspection of the unit, prior to placing it on the patient.Additionally, it was reported that at least five ssv samples were affected.No lot numbers or expiration dates are available.There was no patient involvement.

Manufacturer Narrative

The samples are expected to be returned for an investigation.However, it has not been yet received.(b)(4).

• Brand Name: SHILEY
• Type of Device: SPEAKING VALVE
• Manufacturer (Section D): COVIDIEN; avenida henequen; 1181 parque industrial salvarcar; juarez, chihuahua ; MX
• Manufacturer (Section G): COVIDIEN; avenida henequen; 1181 parque industrial salvarcar; juarez, chihuahua ; MX
• Manufacturer Contact: denise braxton ; 6135 gunbarrel avenue; boulder, CO 80301 ; 3038768909
• MDR Report Key: 4177877
• MDR Text Key: 12390193
• Report Number: 2936999-2014-00896
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 10/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SSV
• Device Catalogue Number: SSV
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1