MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SILICONE CUFF PILOT, SIZE 5; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 105200-000050

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medwatch number ((b)(4)) reported 3 events.Associated mdr numbers: 3011137372-2017-00177, 3011137372-2017-00176.Additional information obtained clarified alleged device malfunction: "the cuff on the lma could not be deflated.The manometer shows in the yellow, which should be totally deflated, but the cuff is still inflated." alleged issue reported as detected during use.No patient harm reported.The device has been received for evaluation, however the evaluation of said device is still in progress at the time of this report.This report will be updated at the conclusion of the device evaluation.

Event Description

Customer complaint received via medwatch ((b)(4)) alleges that the "cuff pilot does not allow air to be put in or taken out of the laryngeal mask airway (lma)".

Manufacturer Narrative

(b)(4).Medwatch number ((b)(4)) reported 3 events.Associated mdr numbers: 3011137372-2017-00177, 3011137372-2017-00176.A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The sample was returned for evaluation.The sample was sent to the supplier for evaluation.The supplier reports that the sample was tested with two different syringes and the cuff was able to be inflated and deflated.The supplier reports that to properly inflate and deflate the cuff push the syringe into the outer cylinder with strength, then rotate the syringe about 45 air can then be inflated or deflated from the cuff.Based on the investigation performed the reported complaint could not be confirmed.There were no issues found with the returned device.

Event Description

Customer complaint received via medwatch ((b)(4)) alleges that the "cuff pilot does not allow air to be put in or taken out of the laryngeal mask airway (lma)".

• Brand Name: LMA UNIQUE SILICONE CUFF PILOT, SIZE 5
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6578117
• MDR Text Key: 75537172
• Report Number: 3011137372-2017-00178
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/01/2019
• Device Catalogue Number: 105200-000050
• Device Lot Number: LQAFQ7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2017
• Initial Date FDA Received: 05/19/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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