MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 4

Catalog Number 175040

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Upon removing the device from the packaging, the gastric port and tube appeared to blocked.The issue was discovered when checking the device prior to patient use.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 there were abnormalities at the connector to drain tube joint.It was also noticed there was glue inside the drain tube channel.Functional testing was performed and the cuff was inflated and no leaks were detected.The og tube insertion test was performed and the tube could not be inserted.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint was confirmed.The product failed the gastric tube insertion into the drain tube as there was presence of adhesive inside the drain tube.This failure happens during the auto gluing between the connector to the drain tube.The glue was dispensed incorrectly inside the drain tube.A non-conformance was opened to address this issue.

Event Description

Upon removing the device from the packaging, the gastric port and tube appeared to blocked.The issue was discovered when checking the device prior to patient use.Patient condition reported as "fine".

• Brand Name: LMA SUPREME SIZE 4
• Type of Device: LMA SUPREME
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 9122617
• MDR Text Key: 182596919
• Report Number: 9681900-2019-00043
• 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: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/28/2021
• Device Catalogue Number: 175040
• Device Lot Number: NMC6LK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.