MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE (SILICONE) CUFF PILOT 3; AIRWAY, OROPHARYNGEAL, ANESTH

Catalog Number 105200-000030

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that after the lma was inserted, the cuff would not inflate."the black scale in cuff pilot was still in the same position, so doctor changed to the new one bust still similar, doctor changed to the new lma again, it worked.Doctor tried to investigate by checking cuff pilot under the water, they found that there was some leakage between cuff pilot housing and tubing." no report of patient harm or injury.The patient status is reported as "fine".See associated mdr# 3009307931-2023-00004.

Manufacturer Narrative

(b)(4) additional information received on 24 jan 2024 states that the deflation occured prior to use on the patient.No patient involvement.The sample was not returned to the manufacturer for evaluation.The manufacturer reported: "there are no actual complaint samples returned to kulim site for investigation.Complaints photos and videos were provided for evaluation from the customer.A device history record review was performed, and no relevant findings were identified.Despite no complaint samples, it was confirmed that the cuff pilot valve was leaking based on the video provided from the customer.Therefore, the root cause is considered to be "manufacturing related".A non-conformance was opened by the manufacturing site to further evaluate this issue."teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a, corrected data: n/a.

Event Description

It was reported that after the lma was inserted, the cuff would not inflate."the black scale in cuff pilot was still in the same position, so doctor changed to the new one bust still similar, doctor changed to the new lma again, it worked.Doctor tried to investigate by checking cuff pilot under the water, they found that there was some leakage between cuff pilot housing and tubing." no report of patient harm or injury.The patient status is reported as "fine".See associated mdr# 3009307931-2023-00004.

• Brand Name: LMA UNIQUE (SILICONE) CUFF PILOT 3
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTH
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY (M) SDN. BHD; lot 19 , jalan hi-tech 3; zon industri fasa 1, kulim hi-tech park; kulim kedah 09090 ; MY 09090
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18402229
• MDR Text Key: 331677687
• Report Number: 3009307931-2023-00005
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: TH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2023

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: 105200-000030
• Device Lot Number: 11F22J0501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 05/20/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2022
• 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