MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 1.5

Catalog Number 175015

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2019

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The complaint is reported as: "the user was unable to insert a airway tube into the hypopharynx.Therefore, the device was replaced with a new one".No patient injury reported.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.The manufacturing facility reports that a visual exam was performed and there were no defects observed.It was also reported that there were no angle issues on the device.The cuff was able to fully inflate.No leakage or improper assembly was detected.The dhr was reviewed and no issues were found.Based on the investigation performed, the reported complaint could not be confirmed.The cuff, back plate, and airway tube were flexible and the angle of the device was acceptable.There were no issues found with the returned device.

Event Description

The complaint is reported as: "the user was unable to insert a airway tube into the hypopharynx.Therefore, the device was replaced with a new one." no patient injury reported.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

The complaint is reported as: "the user was unable to insert a airway tube into the hypopharynx.Therefore, the device was replaced with a new one." no patient injury reported.

• Brand Name: LMA SUPREME SIZE 1.5
• Type of Device: LMA SUPREME
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 8667729
• MDR Text Key: 147060976
• Report Number: 9681900-2019-00016
• 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,Followup
• Report Date: 05/10/2019

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 Expiration Date: 06/28/2020
• Device Catalogue Number: 175015
• Device Lot Number: MMA8JT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 06/04/2019
• Supplement Dates Manufacturer Received: 06/26/2019; 07/24/2019
• Supplement Dates FDA Received: 06/29/2019; 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED