MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 4

Catalog Number 175040

Device Problem Gas/Air Leak (2946)

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

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported cuff leak "during manual mechanical ventilation after the product is placed in the patient, and the effect of adjusting the position of the laryngeal mask is not good.The ventilation effect is ideal after changing to a new one".No patient injury or desaturation reported.Patient condition reported to be fine.Device was replaced.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and no abnormalities were found on the joint area.Leak testing was performed and the cuff was able to inflate and deflate with no issues.The device was then submerged in water and no bubbles were observed indicating no leakage.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.The cuff on the device could be fully deflated and inflated at 45 ml.

Event Description

It was reported cuff leak "during manual mechanical ventilation after the product is placed in the patient, and the effect of adjusting the position of the laryngeal mask is not good.The ventilation effect is ideal after changing to a new one".No patient injury or desaturation reported.Patient condition reported to be fine.Device was replaced.

• Brand Name: LMA SUPREME SIZE 4
• Type of Device: LMA SUPREME
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11037009
• MDR Text Key: 222323530
• Report Number: 9681900-2020-00022
• 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: 11/26/2020

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 Expiration Date: 06/28/2022
• Device Catalogue Number: 175040
• Device Lot Number: PMBPY9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 03/04/2021
• Supplement Dates FDA Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.