MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SIZE 4

Catalog Number	125040
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the device did not inflate post insertion in the theatre".As a result, the patient was extubated and a new lma unique was inserted.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "the device did not inflate post insertion in the theatre".As a result, the patient was extubated and a new lma unique was inserted.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).One unit was received for evaluation.Sample size was the sample as complaint description.From the visual inspection no abnormality found.Leak test was performed to actual complaint sample to review the functionality of the device.Cuff been soaked into the water and no presence of bubble at cuff area & jointing found.By deflating the cuff fully and inflate the cuff as per the instruction for use.No abnormality found, cuff can be inflated and deflated normally.This step was executed 10 times.A device history record review was performed, and no relevant findings were identified.Since functional test already been performed to the actual complaint sample and no abnormality found, complaint concluded as no problem found on sample.This complaint identifies as non-manufacturing related since no problem found on sample.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "the device did not inflate post insertion in the theatre".As a result, the patient was extubated and a new lma unique was inserted.No patient harm or injury.The patient status is reported as "fine".

• Brand Name: LMA UNIQUE SIZE 4
• Common Device Name: LMA UNIQUE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY (M) SDN. BHD; lot 19 , jalan hi-tech 3; zon industri fasa 1, kulim hi-tech park; kulim kedah 09090 ; MY 09090
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18953820
• Report Number: 3009307931-2024-00012
• Device Sequence Number: 12532251
• Product Code: CAE
• UDI-Device Identifier: 15060112314718
• UDI-Public: 15060112314718
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2024

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 Expiration Date: 07/02/2025
• Device Catalogue Number: 125040
• Device Lot Number: 11F22G0033
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 04/05/2024; 05/20/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 04/23/2024; 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2022
• 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 Age: 34 YR
• Patient Sex: Female