MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 4

Model Number	IPN922811
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
It was reported that the doctor found cuff leakage when using it on the patient.It was changed to a new one.
Event or Problem Description
It was reported that the doctor found cuff leakage when using it on the patient.It was changed to a new one.
Additional Manufacturer Narrative
Qn# (b)(4).The actual sample was received for observation.The product complaint received with lma supreme size 4.Lot number cannot be verified due to no pouch provided.A leak test was performed on the sample and there was no presence of bubble identified on the cuff and joint area.The lot number is identified as unknown.There was no problem found on the sample.Based on the complaint description, the complaint related to cuff leakage when using it on the patient.Visual inspection on joint area no abnormality found.Leak test was performed on the sample and no bubbles or no leak at the cuff and joint area.In conclusion, the root cause of the failure was identified as no problem found on the sample.

• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15959081
• Report Number: 9681900-2022-00034
• Device Sequence Number: 11990092
• Product Code: CAE
• UDI-Device Identifier: 35060112318093
• UDI-Public: 15060112318099
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2022

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: IPN922811
• Device Catalogue Number: 175040
• Device Lot Number: PMBBDU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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