MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROSEAL, REU, SIZE 4; LARYNGEAL MASK AIRWAY

Catalog Number 15140

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2016

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 mask was leaking after insertion.There was no patient harm reported.

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.Device was used and not in the original teleflex lma packaging.The connector was observed to be broken.The device could be inflated and deflated smoothly (holding air as intended).The device was tested in the water and there was no leak observed.The connector returned broken from the joint of the airway was most likely due to sudden abrupt force being applied when removing the connector.The reported defect of a leaking mask was unconfirmed as the device could be inflated and deflated as intended.

Event Description

The event is reported as: the customer alleges the mask was leaking after insertion.There was no patient harm reported.

• Brand Name: LMA PROSEAL, 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: 6184221
• MDR Text Key: 62688309
• Report Number: 9681900-2016-00060
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 15140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2017
• 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