MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 1.5

Catalog Number 175015

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2019

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The complaint is reported as: "the user was unable to insert an esophagus tube into drain tube.Therefore, the unit was replaced with a new one".No patient injury was reported.

Event Description

The complaint is reported as: "the user was unable to insert an esophagus tube into drain tube.Therefore, the unit was replaced with a new one." no patient injury was reported.

Manufacturer Narrative

(b)(4).The sample was returned and forwarded to the manufacturer for evaluation.The manufacturer reports: "no damage observed from the outer profile of the device.One og tube was returned along with the device.The complaint sample was then subjected to functional test.The og tube was inserted into drain tube at connector area and it cannot pass through the joint of drain tube even at the connector area.In the end the og tube was unable to go through until the distal end and came out.The dhr was reviewed.No abnormality was found." "on the complaint sample received, the og tube was unable to go through the drain tube until it came out of the sample.In conclusion, the incident was manufacturing related.Relevant parties were made aware of the incident and follow-up action shall be in place to closely monitor the trend of the incident.".

• Brand Name: LMA SUPREME SIZE 1.5
• Type of Device: LMA SUPREME
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 8697012
• MDR Text Key: 148160722
• Report Number: 9681900-2019-00017
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

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: 06/28/2020
• Device Catalogue Number: 175015
• Device Lot Number: MMA8JT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Initial Date Manufacturer Received: 05/24/2019
• Initial Date FDA Received: 06/13/2019
• Supplement Dates Manufacturer Received: 07/12/2019
• Supplement Dates FDA Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1