MAUDE Adverse Event Report: THE LARYNGEAL MASK COMPANY LMA CLASSIC, REU, SIZE 4; LARYNGEAL MASK AIRWAY

Catalog Number 10140

Device Problem Hole In Material (1293)

Patient Problem No Patient Involvement (2645)

Event Date 01/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

Event Description

The event is reported as: the customer alleges a pin hole was detected during pre-test.There was no reported patient involvement.

Manufacturer Narrative

(b)(4).A device history record (dhr) review was performed and there were no issues found that could have contributed to the reported failure.All processes were executed according to standard operating methods.The device was received and observed to be discolored and have stains on the airway surface.Additionally, the cuff profile was deformed as the surface was uneven.The device was functionally tested and was unable to stay inflated due to an air leak.The sample was immersed into water and two leaks were detected on the cuff.The reported complaint was confirmed through functional inspection.Customer is reminded that the lma reusable airway device should be handled with care.The device should not be in close contact with objects that have sharp or hard edges otherwise this will have irreparable damage on the silicone material of the device.

Event Description

The event is reported as: the customer alleges a pin hole was detected during pre-test.There was no reported patient involvement.

• Brand Name: LMA CLASSIC, REU, SIZE 4
• Type of Device: LARYNGEAL MASK AIRWAY
• Manufacturer (Section D): THE LARYNGEAL MASK COMPANY; singapore
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY; 6 battery road #07-02; singapore 04990 9; SN 049909
• Manufacturer Contact: warrenda peterson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193613959
• MDR Report Key: 5403706
• MDR Text Key: 37341961
• Report Number: 9681900-2016-00005
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2016

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: Health Professional
• Device Catalogue Number: 10140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2016
• Initial Date FDA Received: 02/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1