MAUDE Adverse Event Report: TIANJIN MEDIS INTERNATIONAL TRADE CO. ULTRA CLEAR LARYNGEAL MASK; LARYNGEAL MASK AIRWAY

Model Number 1036050

Device Problem Misassembled (1398)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/23/2013

Event Type  malfunction  

Event Description

Laryngeal mask cuff separated from laryngeal mask tube while being removed from patient.

Manufacturer Narrative

The device history record was reviewed and no issue that could have contributed to the reported failure were noted.The device was manufactured according to release specification.After we evaluated the complaint samples, we found that the complaint goods must be re-sterilized under high temperature.So after high temperature, the tube shrank.Please note that it is high temperature, the tube shrank.Please note that it is a single use product, can not be sterilized under high temperature.So our conclusion is the root cause of this complaint is error use.

• Brand Name: ULTRA CLEAR LARYNGEAL MASK
• Type of Device: LARYNGEAL MASK AIRWAY
• Manufacturer (Section D): TIANJIN MEDIS INTERNATIONAL TRADE CO.; tianjin, tianjin ; CH
• Manufacturer Contact: 10-a tianzhi industrial center, no. 12 hong yuan rd.; xiqing economic development zone; tianjin, tianjin 30038-5 ; 6228837992
• MDR Report Key: 4232183
• MDR Text Key: 18036792
• Report Number: 3004992992-2014-00001
• 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: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2016
• Device Model Number: 1036050
• Device Catalogue Number: 1036050
• Device Lot Number: 0520000002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2014
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/17/2014
• Device Age: 8 MO
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 02/27/2014
• Date Manufacturer Received: 03/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention