MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA FLEXIBLE, REU, SIZE 2.5 (110025); AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 11125

Device Problems Leak/Splash (1354); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 01/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has not been returned to the manufacturer at the time of this report.The investigation into this complaint is still in progress.

Event Description

Customer complaint alleges the device "seems to have a slit where the airway tube connects with the mask, resulting in a leak".Alleged defect detected during pre-testing.No report of patient involvement.

Manufacturer Narrative

(b)(4).The device was returned for evaluation.The serial number was reported as (b)(4); however, the lot number of the sample received is asrd99144011.The returned device was compared to a retained sample at the investigation lab.Both the connector shape and the print on the airway tube surface were different from what a typical lma flexible should be like from 2002 to present.Based on the serial number of the returned device (asrd99144011), it was discovered that it was manufactured in 1999.No original packaging and no usage record card listing the date of first use were returned.The complaint device was able to deflate and inflate normally and no leaks were found.Based on the investigation performed, the reported complaint could not be confirmed.No leaks were found with the returned device; however, it was manufactured in 1999 and out of warranty.

Event Description

Customer complaint alleges the device "seems to have a slit where the airway tube connects with the mask, resulting in a leak".Alleged defect detected during pre-testing.No report of patient involvement.

• Brand Name: LMA FLEXIBLE, REU, SIZE 2.5 (110025)
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY; 6 battery road #07-02; singapore 04990 9; SN 049909
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6327137
• MDR Text Key: 67320154
• Report Number: 9681900-2017-00007
• 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: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2017

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: No Information
• Device Catalogue Number: 11125
• Device Lot Number: SN 9JRAA4PH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2017
• Initial Date FDA Received: 02/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/1999
• 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