MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROSEAL, REUSABLE, SIZE 2.5

Catalog Number 15125

Device Problem Deflation Problem (1149)

Patient Problem No Patient Involvement (2645)

Event Date 03/21/2019

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The complaint is reported as: "the facility reported no function of the check valve (no deflation attainable) after 7-time usages".The issue was detected prior to use on a patient during inspection/functional testing.

Event Description

The complaint is reported as: "the facility reported no function of the check valve (no deflation attainable) after 7-time usages." the issue was detected prior to use on a patient during inspection/functional testing.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the airway tube of the device was yellowish.No damage was observed on the device.The device was unable to be inflated and deflated via the check valve when tested.A device history record (dhr) review was performed and there were no issues found that could be related to the reported complaint.Based on the investigation performed, the reported complaint was confirmed.It is suspected that some very tiny debris/substances might have been brought into the check valve while reprocessing over the years (since february 2013) that led to the valve mechanism failure.

• Brand Name: LMA PROSEAL, REUSABLE, SIZE 2.5
• Type of Device: LMA PROSEAL
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 8617283
• MDR Text Key: 145631854
• Report Number: 9681900-2019-00010
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 04/22/2019

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: 15125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Initial Date Manufacturer Received: 04/22/2019
• Initial Date FDA Received: 05/16/2019
• Supplement Dates Manufacturer Received: 06/03/2019
• Supplement Dates FDA Received: 06/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NOT REPORTED.; NOT REPORTED.