MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SILICONE PILOT BALLOON SIZE 4; AIRWAY, OROPHARYNGEAL, ANESTH

Model Number IPN923487

Device Problem Disconnection (1171)

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

Event Date 11/09/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported that "disconnection of the cuff of the laryngeal mask during removal; the cuff remained in the airway the patient did not suffer any damage, all parts could be removed.".

Manufacturer Narrative

(b)(4).From the complaint description, the complaint is concluded as "manufacturing related" as the photo shows the product detached at bet ween the backplate and airway tube.There was also no patient restrain or patient bite or the intention to remove the product forcefully that could cause the failure during removing the product from patient.This complaint was concluded as confirmed complaint and shall be further evaluated in the investigation opened within teleflex and risk evaluation shall be initiated to evaluate or assess the risk of the product in the market.A dhr for the packaging lot was reviewed and no abnormalities was found with the complaint lot.No findings or reject on different size of product was observed during the packaging process.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that "disconnection of the cuff of the laryngeal mask during removal; the cuff remained in the airway the patient did not suffer any damage, all parts could be removed.".

• Brand Name: LMA UNIQUE SILICONE PILOT BALLOON SIZE 4
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTH
• 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: 18289503
• MDR Text Key: 330133395
• Report Number: 9681900-2023-00027
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/13/2023

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: IPN923487
• Device Catalogue Number: 105300-000040
• Device Lot Number: 11F22K0450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 12/11/2023
• Supplement Dates FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2022
• 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