MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 3

Model Number	IPN902070
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the doctor found cuff leakage during using on the patient".No harm or injury reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports: "complaint sample received, and visual inspection was performed on the product.Product complaint received was same as complaint description 1 piece with lma supreme size 3.Lot number can't be verified due to no pouch provided.When device was visually inspected, a tear at inflation balloon area was observed.Part (inflation balloon) was submerged in water and leak test was performed.Observation: bubbles detected.It was confirmed leak.Dhr was reviewed.No abnormality was found." the root cause was found to be manufacturing related.A non-conformance was opened to address this issue.
Event or Problem Description
It was reported that "the doctor found cuff leakage during using on the patient".No harm or injury reported.Patient condition reported as "fine".

• Brand Name: LMA SUPREME SIZE 3
• 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: 12553702
• Report Number: 9681900-2021-00029
• Device Sequence Number: 19940494
• Product Code: CAE
• UDI-Device Identifier: 05060112310812
• UDI-Public: 05060112310812
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2021

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
• Device Expiration Date: 11/28/2022
• Device Model Number: IPN902070
• Device Catalogue Number: 175030
• Device Lot Number: PMCYNK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2019
• 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