MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE (SILICONE) CUFF PILOT 5; AIRWAY, OROPHARYNGEAL, ANESTH

Catalog Number 105200-000050

Device Problem Deflation Problem (1149)

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

Event Date 07/26/2023

Event Type  malfunction  

Event Description

It was reported that prior to use, "the device failed to say deflated after the air was removed.The syringe was used to remove the air, removed and [then] make inflated again".No patient involvement.

Manufacturer Narrative

(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.

Manufacturer Narrative

(b)(4).Complaint sample was received at the manufacturing facility.The product was inspected and tested for leak test in water.Result shows that there is leak at the cpv welding area.Based on the complaint description and review of dhr for the affected lot, no abnormalities were identified.There was also no nonconformances raised during the production of the lot.Based on the investigation and the complaint sample received, it was clearly observed that the product was having a leak at the cuff pilot valve (cpv) and concluded that the root cause was "manufacturing related".Therefore, further evaluation shall be recorded in a nonconformance, and the risk assessment shall be completed through risk evaluation.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that prior to use, "the device failed to say deflated after the air was removed.The syringe was used to remove the air, removed and [then] make inflated again".No patient involvement.

• Brand Name: LMA UNIQUE (SILICONE) CUFF PILOT 5
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTH
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia NC 34600 ; MY 34600
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 17542473
• MDR Text Key: 321090117
• Report Number: 3011137372-2023-00207
• 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
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 105200-000050
• Device Lot Number: 11F23B0035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/07/2023
• 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