MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 5

Model Number IPN922812

Device Problems Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)

Patient Problems Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2022

Event Type  Injury  

Event Description

It was reported that:" tube to blow the cuff od the larynxmask was broken (kink in the tube).".

Manufacturer Narrative

(b)(4).

Event 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".

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
• Type of Device: 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
• MDR Text Key: 306256860
• Report Number: 9681900-2022-00029
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 05060112310836
• UDI-Public: 05060112310836
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 10/06/2022
• Supplement Dates Manufacturer Received: 10/31/2022
• Supplement Dates FDA Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention