MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE EVO CUFF PILOT SIZE 4; AIRWAY, OROPHARYNGEAL, ANESTH

Model Number	IPN923208
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Reported event: silicone was sheared off one part of the cuff and was hanging in the airway.The clinician retrieved it without incident with no consequence to the patient.
Additional Manufacturer Narrative
(b)(4).Based on the review of the device history and non-conformance list, there is no issue of product sheared off or detached or any similar issue.There is also no complaint sample returned for complete and thorough investigation on what is the failure and where it happens.The root cause was unable to be determined and further investigation only can be reissued or carried out once the complaint sample is returned to kulim plant.Therefore, the current root cause of this complaint report is concluded as undetermined/unknown.
Event or Problem Description
Reported event: silicone was sheared off one part of the cuff and was hanging in the airway.The clinician retrieved it without incident with no consequence to the patient.

• Brand Name: LMA UNIQUE EVO CUFF PILOT SIZE 4
• Common Device Name: AIRWAY, OROPHARYNGEAL, ANESTH
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY; 6 battery road #07-02; singapore NC 04990 9; SN 049909
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16216094
• Report Number: 3011137372-2023-00011
• Device Sequence Number: 20677000
• Product Code: CAE
• UDI-Device Identifier: 15060112318884
• UDI-Public: 15060112318884
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2022

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 Model Number: IPN923208
• Device Catalogue Number: 1D2040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2022
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown