MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 5

Model Number	IPN922812
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that:" tube to blow the cuff od the larynxmask was broken (kink in the tube).".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "tube to blow the cuff od the larynxmask was broken (kink in the tube).This caused difficulties to ventilate the patient.Uses a new mask, was fine, but this took extra time and difficulty to ventilate patient".The current condition of the patient was reported as "fine".
Additional Manufacturer Narrative
(b)(4).Additional information received from the sales rep indicates the customer reported that the device was visually inspected prior to use on the patient and a kink in the inflation line was not detected.It was also reported that the device was in place "max 2 minutes, because the cuff wasn't inflated and patient was desaturated." in addition, it was reported that "after inserting the lma and the cuff inflation, the customer noticed the kink and leakage.The patient started to desaturate due to the leak.As a result, the lma was not inflated." the actual device was returned and sent to the manufacturing site for evaluation.The manufacturing site reports: "the complaint sample was received.The report inflation line kinked location was observation at the first glance.There was no hole/leak identified at the kinked inflation line.However air leak found at the cuff area (parting line) during leak test.A testing was conducted during packaging process to simulate the customer complaint received related to inflation line kink.For this testing, inflation line was not placed to correct location during loading the product into packing machine.After the packaging process, the sample product and packaging pouch was reviewed.Visual inspection was performed on the product and pouch, there was no kink identify.The inflation line was totally clean cut if there was improper loading product/inflation line into packaging process.Inflation line condition at sealing area also don't see defect related to kink due to at the sealing area was cover by rubber gasket and control pressure use for sealing process." a device history record review was performed and no relevant findings were identified.Based on the investigation performed the kink in the inflation line was confirmed.There was no hole/leak found in the inflation line; however a tear in the parting line of the cuff was identified.The root cause of the tear is listed as manufacturing related.A non-conformance was opened to address this issue.Corrected data: section h1: type of reportable event changed to 'serious injury'.Section h6: medical device problem code corrected from 2981 to 2889.Section h6: health effect impact code corrected from 4635 to 4642.

• Brand Name: LMA SUPREME SIZE 5
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15550939
• Report Number: 9681900-2022-00029
• Device Sequence Number: 16839275
• Product Code: CAE
• UDI-Device Identifier: 05060112310836
• UDI-Public: 05060112310836
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2025
• Device Model Number: IPN922812
• Device Catalogue Number: 175050
• Device Lot Number: 11F22A0234
• 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: 09/12/2022
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown