MAUDE Adverse Event Report: TELEFLEX ASIA PTE LTD LMA PROSEAL, REU, SIZE 4; LARYNGEAL MASK AIRWAY

Catalog Number 15140

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 03/25/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the valve would not connect with a 10cc syringe in order to inflate the cuff prior to use.There was no patient involvement.

Manufacturer Narrative

The device sample was not returned for evaluation at the time of this report.

• Brand Name: LMA PROSEAL, REU, SIZE 4
• Type of Device: LARYNGEAL MASK AIRWAY
• Manufacturer (Section D): TELEFLEX ASIA PTE LTD; 6 battery road #07-02; 0499 09; SN 049909
• Manufacturer (Section G): TELEFLEX ASIA PTE LTD; 6 battery road, #07-02; 0499 09; SN 049909
• Manufacturer Contact: warrenda peterson ; po box 12600; durham, NC 27709 ; 9193613959
• MDR Report Key: 3837840
• MDR Text Key: 4619705
• Report Number: 9681900-2014-00015
• 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: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 15140
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1