MAUDE Adverse Event Report: BESMED HEALTH BUSINESS CORPORATION AURA 40 REUSABLE; LARYNGEAL MASK

Catalog Number 340400000

Device Problem Structural Problem (2506)

Patient Problem Insufficient Information (4580)

Event Date 06/13/2018

Event Type  Injury  

Manufacturer Narrative

Supplier implemented 100% inspection in reference to trimming.Manufacture instruction for use for functional testing prior to device use was not followed by the user.T.

Event Description

The new laryngeal mask was inserted into a patient, there was no hole in the tubing for the oxygen and sevoflurane to enter.

• Brand Name: AURA 40 REUSABLE
• Type of Device: LARYNGEAL MASK
• Manufacturer (Section D): BESMED HEALTH BUSINESS CORPORATION; no. 5, lane 116; wu-kong 2nd r; new taipei city, special municip 24888 ; TW 24888
• MDR Report Key: 12142047
• MDR Text Key: 260707966
• Report Number: 1220828-2018-00007
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/20/2018,07/10/2018

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: Health Professional
• Device Catalogue Number: 340400000
• Device Lot Number: 703F154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/13/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/20/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention