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

Catalog Number 100030

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint was reported as: "herniation of cuff noted on extubation of lma no ongoing concerns with patients.".No patient harm reported.The patient's condition was reported as "fine".

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the airway tube looked slightly yellowish due to multiple uses.The check valve was inspected and found to be functioning.No blockage was detected.The device was then inflated with 1x recommended air volume and no herniation was visible on the cuff.When the device was inflated with 1.5x the recommended air volume, it was noticed that there was a herniation in the cuff.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint was confirmed.Over-inflation is a known cause that leads to cuff herniation.The manufacturer of the device states that high temperature, vacuum, and humid autoclaving environment, and air/moisture left inside the cuff will expand significantly and it will damage the properties of the device to an irreparable condition.It is suspected that some residual air/moisture was left inside the device while handling/reprocessing.The cuff must be completely deflated prior to autoclaving.

Event Description

The complaint was reported as: "herniation of cuff noted on extubation of lma no ongoing concerns with patients." no patient harm reported.The patient's condition was reported as "fine.".

• Brand Name: LMA CLASSIC SIZE 3
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 8864402
• MDR Text Key: 183106205
• Report Number: 9681900-2019-00025
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 100030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Date Manufacturer Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.