MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 1

Model Number	IPN902063
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the bite block part broken when intubated".No patient injury or harm reported.Patient condition reported as "fine".
Event or Problem Description
It was reported "the bite block part broken when intubated".No patient injury or harm reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).The actual sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports a visual exam was performed and it was observed that the connector plug was detached from the airway tube body.A device history record review was performed and no relevant findings were identified.Based on the visual exam the complaint was confirmed.The manufacturing site reports that on the complaint sample received, it was observed that the connector plug was detached from connector body although there was presence of glue all around the connector body (joint area between 'connector body' to 'connector plug').Therefore, it is confirmed that the root cause of the failure was manufacturing related.A non-conformance was opened to address this issue.

• Brand Name: LMA SUPREME SIZE 1
• Common Device Name: LMA SUPREME
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11333803
• Report Number: 9681900-2021-00004
• Device Sequence Number: 1101630
• Product Code: CAE
• UDI-Device Identifier: 05060112310782
• UDI-Public: 05060112310782
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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: IPN902063
• Device Catalogue Number: 175015
• Device Lot Number: PMBN8S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 03/15/2021
• Patient Sequence Number: 1