MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA CLASSIC, REU, SIZE 3 (100030); AIRWAY, OROPHARYNGEAL, ANESTHE

Catalog Number 10130

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported herniation of the cuff during use.The patient condition was reported as "fine".No intervention or patient harm was reported.

Event Description

The customer reported herniation of the cuff during use.The patient condition was reported as "fine".No intervention or patient harm was reported.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and the airway tube looks lightly yellowish due to multiple uses.The check valve was inspected and it was functioning properly.This means air can be blown in and removed from the device smoothly with a syringe and no blockage was detected.When the device was inflated with both 1x and 1.5x the recommended air volume, no issues were detected.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.

• Brand Name: LMA CLASSIC, REU, SIZE 3 (100030)
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 9038704
• MDR Text Key: 182598783
• Report Number: 9681900-2019-00038
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/21/2019

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 Catalogue Number: 10130
• Device Lot Number: 82SAEVPX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Initial Date Manufacturer Received: 08/21/2019
• Initial Date FDA Received: 09/13/2019
• Supplement Dates Manufacturer Received: 10/08/2019
• Supplement Dates FDA Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.