MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA GASTRO CUFF PILOT SIZE 4

Model Number IPN922790

Device Problem Inflation Problem (1310)

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

Event Date 11/03/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: customer checked lma product, the mask did not remain inflated.The issue was identified prior to use.There was no patient involvement.

Manufacturer Narrative

(b)(4).The sample was returned for investigation.A leak test was performed and it was found that there was a leak at the cuff pilot valve (cpv).The root cause was determined to be manufacturing related.A non conformance was opened to address the issue.

Event Description

It was reported that: customer checked lma product, the mask did not remain inflated.The issue was identified prior to use.There was no patient involvement.

• Brand Name: LMA GASTRO CUFF PILOT SIZE 4
• Type of Device: LMA GASTRO CUFF PILOT
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18235913
• MDR Text Key: 329317278
• Report Number: 9681900-2023-00026
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

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 Model Number: IPN922790
• Device Catalogue Number: 1E5040
• Device Lot Number: 11F22F0339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 12/04/2023
• Supplement Dates FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2022
• 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
• Treatment: NOT REPORTED; NOT REPORTED