MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 1.5; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 175015

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

Customer complaint alleges "the user was unable to insert a gastric catheter into drain tube.Therefore, the unit was replaced with a new one".No patient injury reported.Patient condition reported as fine.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.Functional testing was performed and the og tube was inserted into the drain tube at the connector area and it could not pass through the joint of the drain tube even at the connector area.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 complaint was confirmed.The root cause is manufacturing related.A non-conformance was opened to address this issue.

Event Description

Customer complaint alleges "the user was unable to insert a gastric catheter into drain tube.Therefore, the unit was replaced with a new one." no patient injury reported.Patient condition reported as fine.

• Brand Name: LMA SUPREME SIZE 1.5
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 8336812
• MDR Text Key: 139190839
• Report Number: 9681900-2019-00001
• 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: 01/30/2019

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: 175015
• Device Lot Number: LMA7SD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/13/2019
• Supplement Dates Manufacturer Received: 03/19/2019
• Supplement Dates FDA Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GASTRIC CATHETER- SIZE/MANUFACTURER UNKNOWN.; GASTRIC CATHETER- SIZE/MANUFACTURER UNKNOWN.