MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 4

Catalog Number ALBF040SU

Device Problem Device Handling Problem (3265)

Patient Problems Cyanosis (1798); Low Oxygen Saturation (2477)

Event Date 11/28/2023

Event Type  Injury  

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be performed as no lot number was reported.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 Description

It was reported that "supreme lma was placed in the pt at the start of the case.It did not seat well and was readjusted with little to no tidal volumes while the surgeon was operating.I required help from the circulating rn to intubate the pt emergently as the supreme lma failed, as it is a rescue device it should not fail.Pt was blue and o2 sats were in the low 60s.Pt was an easy intubation and o2 sats recovered quickly.This is now the second time this week the supreme lmas have failed during a case of mine requiring emergent intubation.Today another anesthesiologist placed a supreme lma that also failed requiring emergent intubation as the pt was blue and hypoxic.So currently, we have had 3 failed rescue devices in 2 days putting pt safety in danger".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

Manufacturer Narrative

Qn#(b)(4).The sample was not returned to the manufacturer.The manufacturer reported: "no actual sample was received for further investigation.Complaint sample received with tracking number was received but the sample was not lma supreme.Product received as lma flexible with a different serial number.Based on the complaint description and review of dhr for the affected lot, there is no abnormalities was identified.There was also no nc raised during the production of the lot.As there was no complaint sample returned to confirm the actual root cause, then the root cause for this complaint is concluded as 'undetermined/unknown'." teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a corrected data: section d.3 corrected to: teleflex medical athlone wm.

Event Description

It was reported that "supreme lma was placed in the pt at the start of the case.It did not seat well and was readjusted with little to no tidal volumes while the surgeon was operating.I required help from the circulating rn to intubate the pt emergently as the supreme lma failed, as it is a rescue device it should not fail.Pt was blue and o2 sats were in the low 60s.Pt was an easy intubation and o2 sats recovered quickly.This is now the second time this week the supreme lmas have failed during a case of mine requiring emergent intubation.Today another anesthesiologist placed a supreme lma that also failed requiring emergent intubation as the pt was blue and hypoxic.So currently, we have had 3 failed rescue devices in 2 days putting pt safety in danger".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

• Brand Name: LMA SUPREME SIZE 4
• Type of Device: LMA SUPREME
• 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: 18394268
• MDR Text Key: 331329864
• Report Number: 8040412-2023-00409
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

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 Catalogue Number: ALBF040SU
• Device Lot Number: 11F23A0244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/26/2023
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2023
• 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