MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA FLEXIBLE SU SIZE 3; AIRWAY, OROPHARYNGEAL, ANESTHE

Catalog Number 115030

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Patient Involvement (2645)

Event Date 01/23/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Complaint reported as: "anaesthesiologist informed us that upon preparing the product for usage, he noticed that the product swelled from one side so he stopped and didn't use it".No patient involvement reported.

Manufacturer Narrative

Qn#(b)(4).The sample was returned by the customer and sent to the manufacturing site for evaluation.The manufacturing site reports "the check valve of the return sample is functional.It can be deflated and inflated normally.The cuff material of the device was observed loss of its resilience; when it was inflated with 20ml of air (i.E.1x recommended air volume), the air in the sample was unable to fill up the whole cuff.When it was inflated with 40ml (2x of recommended air volume), the cuff profile of sample looks like a photo of the device provided by the customer (swelling on one side).Based on record, there was pdac2s manufactured instead of pdac25 as reported.All products released were performed 100% leaking test.This reported failure mode did not happen during the test.Dhr was reviewed.No abnormality was found.There was no similar incident on the same lot reported from the rest of the world.Customer is kindly advised to inflate lma flexible su with the "maximum inflation volumes (ml)" per ifu.Over-inflation could damage the lma airway device to an irreparable condition.".

Event Description

Complaint reported as: "anaesthesiologist informed us that upon preparing the product for usage, he noticed that the product swelled from one side so he stopped and didn't use it".No patient involvement reported.

• Brand Name: LMA FLEXIBLE SU SIZE 3
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 9695985
• MDR Text Key: 183106437
• Report Number: 9681900-2020-00003
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 01/23/2020

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: Health Professional
• Device Catalogue Number: 115030
• Device Lot Number: PDAC25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/11/2020
• Supplement Dates Manufacturer Received: 03/10/2020
• Supplement Dates FDA Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.