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

Catalog Number 1E5040

Device Problem Inaccurate Information (4051)

Patient Problem Insufficient Information (4580)

Event Date 07/11/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be completed as no lot number was provided.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.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 during use, "customer explained that the outside packaging, the box, states the lma mask is for weights between 30-50 kilograms.However, the mask itself states that the weight is for 50-70 kilograms.They are willing to keep the product and use it as is, but wanted to reach out to make us aware of the potential issue.".

• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17410020
• MDR Text Key: 320056472
• Report Number: 9681900-2023-00020
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 15060112317955
• UDI-Public: 15060112317955
• 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
• Report Date: 07/11/2023

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: 1E5040
• Device Lot Number: 11F22G0042
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2022
• 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