MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME, SU, SIZE 4; LARYNGEAL MASK AIRWAY

Catalog Number 175040

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The sample has been received however the investigation is still in progress.Once the investigation has been completed a follow-up mdr will be submitted.

Event Description

The event is reported as: the customer alleges the balloon was leaking during testing.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.The sample was received used and not in the original teleflex lma packaging.The cuff area was observed to be bulging at the top of the cuff.Additionally, there was a tear found close to that same area that was bulging.A leak test was performed as the cuff was fully deflated using the syringe.Then the deflated device was immersed into a beaker of water.The cuff was then inflated with 45 ml of air.The cuff was left inflated in the water and alter the device was inspected.The presence of bubbles was checked by rotating the product.There were bubbles at the parting line of the cuff near the bulging area.The root cause of the complaint was in the vent tab installation process.The vent tab was not installed correctly or fell down from the check valve.This will impact the product during sterilization process.When the vent tab is not correctly installed, the cuff will over inflate and probably tear/leak (during vacuum process).A containment action was conducted to avoid this issue from happening again.The operators were re-trained on the relevant operation procedure.

Event Description

The event is reported as: the customer alleges the balloon was leaking during testing.There was no patient involvement reported.

• Brand Name: LMA SUPREME, SU, SIZE 4
• 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: 6095715
• MDR Text Key: 59727081
• Report Number: 9681900-2016-00045
• 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: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 175040
• Device Lot Number: JMAWN3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2016
• 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