MAUDE Adverse Event Report: TELEFLEX THE LMA® UNIQUE¿ (SILICONE CUFF) AIRWAY; LMA/ UNIQUE (SILICONE CUFF) CUFF POILET

Catalog Number 105200-000050

Device Problem No Flow (2991)

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

Event Date 03/27/2017

Event Type  malfunction  

Event Description

The cuff pilot (manometer) does not allow air to be put in or taken out of the cuff of the laryngeal mask airway (lma) unique size 5 w/silicone cuff.The rep has been notified and he is ordering replacements.The entire product has the same lot # of lqafq7.

• Brand Name: THE LMA® UNIQUE¿ (SILICONE CUFF) AIRWAY
• Type of Device: LMA/ UNIQUE (SILICONE CUFF) CUFF POILET
• Manufacturer (Section D): TELEFLEX; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 6489708
• MDR Text Key: 72695077
• Report Number: 6489708
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2017

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: 105200-000050
• Device Lot Number: LQAFQ7
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2017
• 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