MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA FLEXIBLE, REU, SIZE 2; LARYNGEAL MASK AIRWAY

Catalog Number 11120

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2016

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 is leaking at the cuff during use.There is no reported harm to the patient.

Manufacturer Narrative

(b)(4).Device history record (dhr) review was performed and there were no issues found that could have contributed to the reported failure.The used device was not received in the original teleflex lma packaging.The airway was observed to be clear.Two cuts were observed on both sides of the cuff tip.The device was verified unable to hold air when being tested upon receipt.The leak was confirmed by further testing in the water.The front and back of the cuff was observed to have bubbles escaping.The reported defect was confirmed.The device most likely got punctured inadvertently due to handling after the device was unpacked.Customer is reminded that the lma should be handled with care.Placing, washing or autoclaving device with objects that have sharp edges should be avoided.Otherwise this will have an adverse impact to the silicone material of the cuff and will have irreparable and permanent damage to its properties.

Event Description

The event is reported as: the customer alleges the device is leaking at the cuff during use.There is no reported harm to the patient.

• Brand Name: LMA FLEXIBLE, REU, SIZE 2
• 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: 6144461
• MDR Text Key: 61450863
• Report Number: 9681900-2016-00051
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 11120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2017
• 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