MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE EVO, CUFF PILOT, SU, SIZE 4; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 1D2040

Device Problems Shelf Life Exceeded (1567); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation into this complaint is still in progress at the time of this report.

Event Description

Customer complaint alleges"the cuff pilot valve was not working properly.When attempting to deflate or inflate the cuff, the valve seemed stuck." alleged defect reported as detected during pre-testing, prior to patient use.It was reported there was no complications or injury to the patient.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).The device history record was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The sample was not returned for evaluation; therefore, the complaint could not be confirmed.

Event Description

Customer complaint alleges"the cuff pilot valve was not working properly.When attempting to deflate or inflate the cuff, the valve seemed stuck." alleged defect reported as detected during pre-testing, prior to patient use.It was reported there was no complications or injury to the patient.Patient condition reported as "fine".

• Brand Name: LMA UNIQUE EVO, CUFF PILOT, SU, SIZE 4
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6896826
• MDR Text Key: 87465837
• Report Number: 3011137372-2017-00285
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2017

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: No Information
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 1D2040
• Device Lot Number: LQAFFR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2017
• Initial Date FDA Received: 09/27/2017
• Supplement Dates Manufacturer Received: 11/06/2017
• Supplement Dates FDA Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2016
• 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