MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 5

Model Number IPN902076

Device Problem Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint reported as: "before use a leak - cuff - was discovered.Defect was observed after opening of the package and during leak test first usage)".

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and it was found there was a tear on the parting line of the cuff.A leak test was performed and the device was found to leak at the location of the tear.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint was confirmed.A tear was found on the parting line of the cuff.Leaking was found at the location of the tear.The root cause was found to be manufacturing related.A non-conformance was opened to address this issue.

Event Description

Customer complaint reported as: "before use a leak - cuff - was discovered.Defect was observed after opening of the package and during leak test first usage)".

• Brand Name: LMA SUPREME SIZE 5
• Type of Device: LMA SUPREME
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 10303532
• MDR Text Key: 201737353
• Report Number: 9681900-2020-00007
• 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: 07/06/2020

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: 03/28/2022
• Device Model Number: IPN902076
• Device Catalogue Number: 175050
• Device Lot Number: PMAS5W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1