MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 2

Catalog Number 175020

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported an anesthesia machine detected a leak while the device was used on a patient.The mask was changed and it was reported the user observed a detached mask in the cuff area.No patient harm or injury reported.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Photos were provided by the customer; however, it was unable to be determined if the mask detached during use based on the photos.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Customer reported an anesthesia machine detected a leak while the device was used on a patient.The mask was changed and it was reported the user observed a detached mask in the cuff area.No patient harm or injury reported.

• Brand Name: LMA SUPREME SIZE 2
• Type of Device: LMA SUPREME
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 9112536
• MDR Text Key: 182597260
• Report Number: 9681900-2019-00042
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 09/04/2019

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: 04/28/2021
• Device Catalogue Number: 175020
• Device Lot Number: NMA37K
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 09/24/2019
• Supplement Dates Manufacturer Received: 10/11/2019
• Supplement Dates FDA Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.
• Patient Age: 2 YR
• Patient Weight: 16