MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME, SU, SIZE 2.5; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 175025

Device Problem Split (2537)

Patient Problem Extubate (2402)

Event Date 12/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation into this complaint is still in progress.The device involved has not been received by the manufacturer at the time of this report.

Event Description

Customer complaint alleges "first noted there was leakage alarm from ventilator after patient was anaesthetized & easy insertion of lma.When examined, found the lma was split open at the top end / joint & leaking." reported medical intervention was "lma removed".Patient condition reported as "fine".

Event Description

Customer complaint alleges "first noted there was leakage alarm from ventilator after patient was anaesthetized & easy insertion of lma.When examined, found the lma was split open at the top end / joint & leaking." reported medical intervention was "lma removed".Patient condition reported as "fine".

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the connector plug was detached from the connector body.Further observation found that there was the presence of glue all around the connector body.A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.Based on the investigation performed, the reported complaint was confirmed.The root cause was determined to be manufacturing related.Respective parties were made aware of the incident and trending on similar issues shall be closely monitored.

• Brand Name: LMA SUPREME, SU, SIZE 2.5
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 7249097
• MDR Text Key: 99313465
• Report Number: 9681900-2018-00013
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/22/2018

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: No Information
• Device Expiration Date: 08/28/2019
• Device Catalogue Number: 175025
• Device Lot Number: LMBK67
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 02/07/2018
• Supplement Dates Manufacturer Received: 03/08/2018
• Supplement Dates FDA Received: 03/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention