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

Catalog Number 100030

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that during intubation, the cuff was inflated with 20ml of air however "poor ventilatory function" was observed, "no adaptation to the patient".Therefore the mask was removed.After removal a "deformation" was observed.No patient harm or injury or report of desaturation.The patient status is reported as "fine".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.

Manufacturer Narrative

(b)(4), the complaint sample was returned.The manufacturing site reported that one lma classic was reported from the columbia complaint as "the mask observed deformation".The actual complaint sample was received.The product size was same as complaint description.Potentially caused by over-inflation of the mask/cuff by the user.The device worked for 13 times used before problem occurred and so the user might have accidently over-inflated the cuff causing it to bulge.Subsequent inflation will cause it to hemiate due to the memory effect of silicon materials.Teleflex will continue to monitor and trend on reports of this nature.

Event Description

It was reported that during intubation, the cuff was inflated with 20ml of air however "poor ventilatory function" was observed, "no adaptation to the patient".Therefore the mask was removed.After removal a "deformation" was observed.No patient harm or injury or report of desaturation.The patient status is reported as "fine".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.

• Brand Name: LMA CLASSIC SIZE 3
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHE
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17795114
• MDR Text Key: 324015681
• Report Number: 9681900-2023-00024
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2023
• Device Catalogue Number: 100030
• Device Lot Number: NFAB8F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1