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	03/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "the air bag was found leakage during using on the patient".No patient harm, injury, or desaturation reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).The sample was received for evaluation.A visual exam was performed and a tear was found on the parting line on the cuff.Functional testing was also performed and the sample was immersed in water.A bubble was found on the tear location indicating a leak.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint was confirmed.The root cause was found to be manufacturing related.A non-conformance was opened to further address this issue.
Event or Problem Description
It was reported that "the air bag was found leakage during using on the patient".No patient harm, injury, or desaturation reported.Patient condition reported as "fine".

• Brand Name: LMA SUPREME SIZE 3
• Common Device Name: LMA SUPREME
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11613198
• Report Number: 9681900-2021-00007
• Device Sequence Number: 3124928
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

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: No Information
• Device Expiration Date: 06/28/2022
• Device Model Number: IPN902070
• Device Catalogue Number: 175030
• Device Lot Number: PMBMEG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1