MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROTECTOR CUFF PILOT SIZE 3; LARYNGEAL MASK AIRWAY

Catalog Number 192030

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 08/22/2016

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 is leaking 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 in the original teleflex lma packaging with the pouch seal open.When the device was initially observed the distal end of the cuff appeared normal until pressure was put on the cuff.The cuff was deflated and left for 2 seconds.Then the cuff inflated back to the normal shape.The device was immersed into a beaker of water and checked for leakage.A bubble occurred inside the airway tube.A leak was observed from the tear at the distal end of the cuff.The reported defect was confirmed through functional and visual inspection.The possible root cause is suspected to be due to the use of tweezers during the touch up process, while removing glue from the inside of the distal end of the device after the assembly process.The operation work instruction for the gluing method has been revised.

Event Description

The customer alleges the cuff is leaking prior to use.There was no patient involvement reported.

• Brand Name: LMA PROTECTOR CUFF PILOT 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: 5942726
• MDR Text Key: 54426235
• Report Number: 9681900-2016-00037
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2018
• Device Catalogue Number: 192030
• Device Lot Number: KMBMXM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2016
• 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