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

Catalog Number 10140

Device Problem Inflation Problem (1310)

Patient Problem No Patient Involvement (2645)

Event Date 11/12/2015

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 cuff only inflated on one side.There was no reported patient involvement.

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 not received in the original teleflex lma packaging.The device was observed to have been used and had a clear airway tube.The cuff shape was observed deformed upon receipt.A retained sample was compared to the defective sample and the cuff material of the defective sample was observed to be larger than the retained sample.The defective sample was inflated with 1x the recommended air volume and the cuff dimension was observed to be deformed.The reported defect was confirmed through visual and functional inspection.Over-inflation is a known cause that leads to cuff herniation.Customer is kindly reminded that any residual air during autoclave is a commonly known root cause for herniation and internal rupture of the cuff.Other remarks: any air or moisture left in the cuff will expand during high temperature/vacuum/humid autoclave causing irreparable damage to the cu ff and/or inflation balloon.The customer should also completely deflate the cuff before autoclaving the device.

Event Description

The event is reported as: the customer alleges the cuff only inflated on one side.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: 5227145
• MDR Text Key: 31333887
• Report Number: 9681900-2015-00062
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/12/2015

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: 10140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 11/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/08/2016
• 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