MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 4

Catalog Number	175040
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "nurse found there was a leakage on cuff prior to using to patient".No patient involvement reported.
Additional Manufacturer Narrative
(b)(4), the sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports "the complaint sample was received with disinfection label.There was no original product pouch with lot number indicated to be returned along with the sample.The product profile looks standard and normal.The device was able to be deflated and inflated.However, it could not hold air after inflation took place.The device was immersed into water and air bubbles were observed escaping from cuff.The failure location was verified.Dhr was reviewed.No abnormality was found." the complaint has been confirmed.The manufacturing site has determined that the root cause is manufacturing related.A capa was opened to address this issue.
Event or Problem Description
It was reported "nurse found there was a leakage on cuff prior to using to patient".No patient involvement reported.

• Brand Name: LMA SUPREME SIZE 4
• Common Device Name: LMA SUPREME
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY; 6 battery road #07-02; singapore 04990 9; SN 049909
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 13151435
• Report Number: 9681900-2022-00001
• Device Sequence Number: 14805529
• Product Code: CAE
• UDI-Device Identifier: 15060112318099
• UDI-Public: 15060112318099
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/28/2022
• Device Catalogue Number: 175040
• Device Lot Number: PMDKSM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown