MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 4

Catalog Number 175040

Device Problem Deflation Problem (1149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "during the customer intubating, found the balloon was not properly deflation".No patient harm or injury reported.

Event Description

It was reported that "during the customer intubating, found the balloon was not properly deflation".No patient harm or injury reported.

Manufacturer Narrative

Qn# (b)(4).The actual sample was returned and sent to the manufacturing site for investigation.Ups reports that there is an issue with customs and the package was not able to get through.The status of the package is unknown at this time.Another report will be submitted with investigation results if sample is received and able to be evaluated.

Manufacturer Narrative

Qn# (b)(4).The actual sample was returned and sent to the manufacturing site for investigation.The manufacturer reports: "visual inspection performed on the cuff area.There was tear on the cuff observed.The tear was caused by sharp edges during procedure when patient involved.Present of bubbles (leak) at the tear location during leak test".Based on the investigation performed, the reported complaint was confirmed.A tear was found on the cuff.The tear was caused by sharp edges.This complaint sample was being used on the patient and the cuff was most likely cut/punctured with a sharp object during the procedure.

Event Description

It was reported that "during the customer intubating, found the balloon was not properly deflation".No patient harm or injury reported.

• Brand Name: LMA SUPREME SIZE 4
• Type of Device: LMA SUPREME
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11065144
• MDR Text Key: 223798372
• Report Number: 9681900-2020-00023
• 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,Followup
• Report Date: 12/08/2020

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: 175040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 03/02/2021; 03/02/2021
• Supplement Dates FDA Received: 03/02/2021; 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1