MAUDE Adverse Event Report: TELEFLEX ASIA PTE LTD LMA FLEXIBLE, REU, SIZE 5; LARYNGEAL MASK AIRWAY

Catalog Number 11150

Device Problem Hole In Material (1293)

Patient Problem No Patient Involvement (2645)

Event Date 04/09/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that there was a small pin hole observed at the base of the cuff.The cuff failed to maintain inflation.There was no patient involvement.

Manufacturer Narrative

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

• Brand Name: LMA FLEXIBLE, REU, SIZE 5
• Type of Device: LARYNGEAL MASK AIRWAY
• Manufacturer (Section D): TELEFLEX ASIA PTE LTD; 6 battery road; #07-02; singapore 0499 09; SN 049909
• Manufacturer (Section G): TELEFLEX ASIA PTE LTD; 6 battery road; #07-02; singapore 0499 09; SN 049909
• Manufacturer Contact: warrenda peterson ; p.o. box 12600; durham, NC 27709 ; 9193613959
• MDR Report Key: 3820854
• MDR Text Key: 4504695
• Report Number: 9681900-2014-00016
• 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: 04/09/2014

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: 11150
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2014
• Initial Date FDA Received: 04/15/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1