MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROSEAL, REU, SIZE 5; LARYNGEAL MASK AIRWAY

Catalog Number 15140

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); Extubate (2402)

Event Date 10/23/2016

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 air leaked after extubation.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.The device was received and was observed to have a lightly yellowish airway tube.There was also a puncture observed on the rear cuff.The device could not hold air when it was tested.The leak was confirmed by further testing in the water as air bubbles were observed escaping from the rear of the cuff.The reported defect was confirmed.The device was most likely punctured while handling after 22 uses.Customer is reminded that the lma reusable device should not be in close contact with anything that has sharp edges during washing/autoclaving.This will have an adverse impact on the silicone material of the cuff and irreparable damage.

Event Description

The event is reported as: the customer alleges air leaked after extubation.There was no patient harm reported.

• Brand Name: LMA PROSEAL, REU, SIZE 5
• 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: 6184188
• MDR Text Key: 62690284
• Report Number: 9681900-2016-00057
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2016

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: 12/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2017
• 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