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

Catalog Number 100030

Device Problem Break (1069)

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

Event Date 10/04/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).N/a other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that prior to use in the clinical setting, inside the clear packaging it was found that the aperture bar was broken.No patient involvement.

Manufacturer Narrative

Qn#(b)(4).The reported complaint of broken aperture bar was confirmed upon the evaluation of the returned sample.Visual inspection identified broken aperture bar during inflation of the cuff.Based on the customer report and the sample received, the root cause for this issue was likely the user mishandling the device during procedure, cleaning, or storage.No further action was required.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that prior to use in the clinical setting, inside the clear packaging it was found that the aperture bar was broken.No patient involvement.

Manufacturer Narrative

(b)(4).The reported complaint of broken aperture bar was confirmed upon the evaluation of the returned sample.Visual inspection identified broken aperture bar during inflation of the cuff.A device history record review was performed, and no relevant findings were found.Based on the customer report and the sample received, the root cause for this issue was likely the user mishandling the device during procedure, cleaning, or storage.No further action was required.Teleflex will continue to monitor and trend for reports of this nature.Corrected data: dhr information.

Event Description

It was reported that prior to use in the clinical setting, inside the clear packaging it was found that the aperture bar was broken.No patient involvement.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17987634
• MDR Text Key: 326305905
• Report Number: 9681900-2023-00025
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2023

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: 100030
• Device Lot Number: 82ZAA4NU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 11/23/2023; 11/23/2023
• Supplement Dates FDA Received: 11/23/2023; 11/23/2023
• 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