MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA FASTRACH COMBO-KIT, REU, SIZE 4; LARYNGEAL MASK AIRWAY

Catalog Number 13140

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 09/28/2015

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 device was leaking.There was no reported patient involvement.

Manufacturer Narrative

(b)(4).Report source - foreign.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 the standard operating methods.The device was not received in the original teleflex lma packaging.The sample initially appeared to be missing the serial# from the airway tube.However, after further inspection the serial# was observed to be faded but readable.During the initial inspection a rip approximately 2mm long was observed on the orifice of the cuff very near the epiglottis elevator bar (eeb).The device was unable to hold inflation during the functional inspection due to the rip.When the device was immersed into water there were air bubbles observed escaping the device.Additionally, because of the rip on the cuff the eeb on the returned sample was easier to lift compared with the eeb of a retained sample.(see other remarks) other remarks: the reported complaint was confirmed through visual and functional inspection.The reported failure was suspected to be due to the device being torn inadvertently while being handled after some cycles of use.Customer is reminded that the lma reusable airway device should be handled with care while being reprocessed.Customer is also reminded the lma fastrach is reusable and warranted against manufacturing defects for forty (40) uses or a period of one (1) year from the date of purchase (whichever is earlier), subject to certain conditions.The product was manufactured in 2011 and has been out of warranty since 2012.

Event Description

The event is reported as: the customer alleges the device was leaking.There was no reported patient involvement.

• Brand Name: LMA FASTRACH COMBO-KIT, REU, SIZE 4
• Type of Device: LARYNGEAL MASK AIRWAY
• 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: warrenda peterson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193613959
• MDR Report Key: 5144956
• MDR Text Key: 28470792
• Report Number: 9681900-2015-00055
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 13140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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