MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME, SU, SIZE 3; LARYNGEAL MASK AIRWAY

Catalog Number 175030

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2016

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 cuff leaked during inflation.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.Device was used and not in the original teleflex lma packaging.The airway was observed to be clear.Leak test was performed by inflating the cuff using a syringe and the cuff slowly deflated and lost pressure.The leak was detected between the inflation balloon and check valve joint (gluing) when it was tested in the water.The reported defect was confirmed due to the manufacturing of the device.The leak was due to the glue not being properly placed on the joint.This then caused a void that allowed air to escape.Operators have been informed of the incident and continued trending of similar complaints will be monitored.

Event Description

The event is reported as: the customer alleges the cuff leaked during inflation.There was no patient harm reported.

• Brand Name: LMA SUPREME, SU, SIZE 3
• Type of Device: LARYNGEAL MASK AIRWAY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• 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: 6208539
• MDR Text Key: 63382479
• Report Number: 9681900-2016-00061
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 175030
• Device Lot Number: LMAGDX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1