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

Catalog Number 105200-000030

Device Problem Deflation Problem (1149)

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

Event Date 10/16/2017

Event Type  malfunction  

Event 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
• Type of Device: AIRWAY WITH CUFF PILOT¿ TECHNOLOGY, SIZE 3
• Manufacturer (Section D): TELEFLEX INC.; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 6971103
• MDR Text Key: 90041197
• Report Number: 6971103
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 05060112313578
• UDI-Public: (01)05060112313578
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 10/19/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1