MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SIZE 3

Model Number IPN922800

Device Problem Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 02/22/2023

Event Type  malfunction  

Event Description

Reported issue: the cuff was leaking.Another device was used.

Manufacturer Narrative

Qn# (b)(4).The returned device size was the same as the complaint description.Review on the product appearance showed no abnormality such as a tear, burst, or rear at the cuff or joint.A leak test was performed and there was no presence of bubble on the cuff or joint area.A second flow leak test was performed to ensure there was no leak identified at gluing area or cuff to backplate and airway tube to backplate.There was no leak found.The device history review for lot 11f22c0205 was reviewed and there was no nc for that lot during production.No corrective action is required at this time.The root cause was identified as no problem found on the sample.

• Brand Name: LMA UNIQUE SIZE 3
• Type of Device: LMA UNIQUE
• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16569551
• MDR Text Key: 311669392
• Report Number: 9681900-2023-00010
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 15060112318112
• UDI-Public: 15060112318112
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/22/2023

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: IPN922800
• Device Catalogue Number: 125030
• Device Lot Number: 11F22C0205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED