MAUDE Adverse Event Report: TELEFLEX INC LMA UNIQUE SILICONE CUFF PILOT, SIZE 3; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 105200-000030

Device Problem Deflation Problem (1149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2018

Event Type  malfunction  

Manufacturer Narrative

This is a resubmission of initial mdr per request from (b)(4), fda medwatch program.Inital mdr originally submitted on (b)(6) 2018.Mfr report # has been corrected.

Event Description

Customer complaint alleges the user states "the valve in the pilot balloon appeared to be stuck, precluding inflation or deflation of the cuff." photos were submitted for review.Alleged malfunction reported as occurred during use.It was reported that the device was replaced.It was reported there was no patient injury.

• Brand Name: LMA UNIQUE SILICONE CUFF PILOT, SIZE 3
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX INC; athlone, westmeath ; EI
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY; 6 battery road #07-02; 04990 9; SN 049909
• Manufacturer Contact: linda woodall ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 7366840
• MDR Text Key: 247791055
• Report Number: 3011137372-2018-00059
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2018

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 Catalogue Number: 105200-000030
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2018
• Initial Date FDA Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1