MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME, SU, SIZE 2.5; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 175025

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has not been received by the manufacturer at the time of this report.The investigation into this complaint is still in progress.

Event Description

Customer complaint from (b)(6) alleges "above the bite guard at the transition from the tube to the drainage channel there was found a crack." alleged defect reported as detected during use.No report of patient harm or medical intervention.Another device was obtained for use.Patient condition reported as "fine".

Manufacturer Narrative

Qn#: (b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the connector plug was detached from the connector body.Upon further observation it was noticed that the connector plug did not attach properly or did not have a proper contact with the glue placed at the connector body.A cuff leak test and a drain tube leak test were performed and no leakage was found.A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.Based on the investigation performed, the reported complaint was confirmed.The root cause is manufacturing related as it was observed that the connector plug was detached from the connector body.Respective parties were made aware of this issue and trending on similar issues will be closely monitored.

Event Description

Customer complaint from germany alleges "above the bite guard at the transition from the tube to the drainage channel there was found a crack." alleged defect reported as detected during use.No report of patient harm or medical intervention.Another device was obtained for use.Patient condition reported as "fine".

• Brand Name: LMA SUPREME, SU, SIZE 2.5
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; po box 28, kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6824380
• MDR Text Key: 83954813
• Report Number: 8040412-2017-00185
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/09/2017

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 Catalogue Number: 175025
• Device Lot Number: LMA87J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/09/2017
• Initial Date FDA Received: 08/28/2017
• Supplement Dates Manufacturer Received: 09/25/2017
• Supplement Dates FDA Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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