MAUDE Adverse Event Report: THE LARYNGEAL MASK COMPANY LMA PROSEAL, REU, SIZE 3; LARYNGEAL MASK AIRWAY

Catalog Number 15130

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2016

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 air is leaking from the cuff during use.There was no patient harm 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 was observed to be yellowish due to multiple uses.The outer profile of the device was observed to be normal.The device was immersed into water and an air leak was observed.There was glue in place at the joint and a cut of the glue line was found at the joint.There was no significant difference in the gluing of the defective device compared to a retained sample.The reported defect was confirmed during a functional inspection.It is suspected the glue line of the device was damaged by a sharp object inadvertently while being handled/reprocessed after some cycles of use.Customer is reminded the device is made of a soft silicone material.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 air is leaking from the cuff during use.There was no patient harm reported.

• Brand Name: LMA PROSEAL, REU, SIZE 3
• 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: 5790145
• MDR Text Key: 49407979
• Report Number: 9681900-2016-00028
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 15130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2016
• 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