MAUDE Adverse Event Report: TELEFLEX MEDICAL ASIA PTE LTS LMA PROSEAL, REU, SIZE 3 (150030); LARYNGEAL MASK AIRWAY

Catalog Number 15130

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2013

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that there was a tear in the cuff of the device that was discovered by the anesthetist prior to use on a patient.The customer used a different lma device successfully and the defective device was not used.No report of a patient injury or a delay in treatment.

Manufacturer Narrative

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

• Brand Name: LMA PROSEAL, REU, SIZE 3 (150030)
• Type of Device: LARYNGEAL MASK AIRWAY
• Manufacturer (Section D): TELEFLEX MEDICAL ASIA PTE LTS; 6 battery road; #07-02; 0499 09; SN 049909
• Manufacturer (Section G): TELEFLEX MEDICAL ASIA PTE LTD; 6 battery road, #07-02; 0499 09; SN 049909
• Manufacturer Contact: margie burton, rn ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3647329
• MDR Text Key: 4355503
• Report Number: 9681900-2014-00002
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/16/2013

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: 15130
• Device Lot Number: HFAAVG
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2013
• Initial Date FDA Received: 01/06/2014
• 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: Unknown
• Patient Sequence Number: 1