MAUDE Adverse Event Report: THE LARYNGEAL MASK COMPANY LMA CLASSIC EXCEL, REU, SIZE 5; LARYNGEAL MASK AIRWAY

Catalog Number 902050

Device Problem Hole In Material (1293)

Patient Problem No Patient Involvement (2645)

Event Date 06/17/2016

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 the valve has a hole prior to use.There was no patient involvement reported.

Manufacturer Narrative

(b)(4).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 the standard operating methods.The sample was received used and not in the original teleflex lma packaging.The airway tube is observed to be clear and the device has cuts on the inflation balloon surface.Then the device was functionally tested in the water, the device was observed unable to hold air due to the cuts on the inflation balloon surface.The check valve was functioning as air can pass through the check valve smoothly.It is suspected the device was cut inadvertently while being handled after 9 uses.Customer is reminded the device is made of soft silicone rubber.The device should be handled with care and kept away from any sharp or hard objects.Otherwise this will cause irreparable damage to the condition of the device.

Event Description

The event is reported as: the customer alleges the valve has a hole prior to use.There was no patient involvement reported.

• Brand Name: LMA CLASSIC EXCEL, REU, SIZE 5
• 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: 5740096
• MDR Text Key: 47894571
• Report Number: 9681900-2016-00026
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/17/2016

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: No Information
• Device Catalogue Number: 902050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/17/2016
• Initial Date FDA Received: 06/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/10/2016
• 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