MAUDE Adverse Event Report: THE LARYNGEAL MASK COMPANY LMA FASTRACH ETT, SU, SIZE 7.0; LARYNGEAL MASK AIRWAY

Catalog Number 136070

Device Problem Detachment Of Device Component (1104)

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

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

Event Description

The event is reported as: the customer alleges the cuff detached from the tube during use.

Manufacturer Narrative

(b)(4).A device history record (dhr) review was performed and there were no issues found that could have contributed to the reported failure.All processes were executed according to standard operating methods.The device was received (device was used) and the connector and check valve of the ett was observed to be discolored (orange residue).The ett was also observed to have a detached inflation line.The failure location was observed to be sufficiently glued.The check valve was functionally tested and was found to be operating as intended.This means the air was able to pass through the valve smoothly and without blockage.The reported defect was confirmed through visual inspection.The connection of the inflation line and air lumen of the ett was detached due to pulling force that broke the adhesive bond.Customer is kindly reminded not to pull the inflation line when entangled with another object or connected to equipment.Also, the lma single use device is not required to be reprocessed/re-washed prior to use.

Event Description

The event is reported as: the customer alleges the cuff detached from the tube during use.

• Brand Name: LMA FASTRACH ETT, SU, SIZE 7.0
• Type of Device: LARYNGEAL MASK AIRWAY
• Manufacturer (Section D): THE LARYNGEAL MASK COMPANY; singapore
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY; 6 battery road #07-02; singapore 04990 9; SN 049909
• Manufacturer Contact: warrenda peterson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193613959
• MDR Report Key: 5426817
• MDR Text Key: 37850692
• Report Number: 9681900-2016-00006
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2016
• Device Catalogue Number: 136070
• Device Lot Number: HBAAZC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1