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	08/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "the cuff did not inflate during the test before use.Therefore, a new unit was used instead.".
Event or Problem Description
It was reported that: "the cuff did not inflate during the test before use.Therefore, a new unit was used instead.".
Additional Manufacturer Narrative
Qn# (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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Additional Manufacturer Narrative
(b)(4).The sample was returned to the manufacturer for evaluation.The manufacturer reported:" below are photos of complaint sample received on 05 nov 2024 with the disinfection tag.Size was same as complaint description.From the visual inspection no abnormality found.Further investigation will go through functional test.Cuff cannot be inflated using syringe.Review on the check valve area identify there was glue at the "white valve' area.The glue blocks the valve to move, and air cannot be inflated using syringe.Based on the complaint sample received, the complaint root cause is concluded as "manufacturing related".One complaint received from japan related to cuff did not inflate during the test.Based on the complaint description and review of dhr for the affected lot, no abnormalities found.The root cause of this complaint is "manufacturing related" as it was confirmed that the cuff did not inflate.Further escalation and evaluation shall be recorded in a non-conformance." teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that: "the cuff did not inflate during the test before use.Therefore, a new unit was used instead.".

• 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: 20178956
• Report Number: 3009307931-2024-00028
• Device Sequence Number: 8705021
• Product Code: CAE
• UDI-Device Identifier: 15060112314718
• UDI-Public: (01)15060112314718(11)230410(17)260409(10)11F23D0086(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2024

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: 04/09/2026
• Device Catalogue Number: 125040
• Device Lot Number: 11F23D0086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 09/26/2024; 11/22/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 09/30/2024; 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown