MAUDE Adverse Event Report: TELEFLEX INC. LMA UNIQUE; AIRWAY WITH CUFF PILOT¿ TECHNOLOGY, SIZE 3

Catalog Number	105200-000030
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Crna was preparing for case and lma #3 would not deflate.Crna obtained another lma #3 with same results.Could not deflate lma.

• Brand Name: LMA UNIQUE
• Common Device Name: AIRWAY WITH CUFF PILOT¿ TECHNOLOGY, SIZE 3
• Manufacturer (Section D): TELEFLEX INC.; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 6971103
• Report Number: 6971103
• Device Sequence Number: 1117806
• Product Code: CAE
• UDI-Device Identifier: 05060112313578
• UDI-Public: (01)05060112313578
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2017
• Report Date (Section F): 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 11/28/2019
• Device Catalogue Number: 105200-000030
• Device Lot Number: LQAFNB
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/19/2017