MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA FLEXIBLEE SIZE 4; AIRWAY, OROPHARYNGEAL, ANESTHE

Model Number IPN922880

Device Problem Break (1069)

Patient Problems Hypoventilation (1916); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2022

Event Type  Injury  

Event Description

Reported issue: the plastic piece on the bottom of the lma #4 that attaches to the syringe to inflate is broken and will not allow the air to pass.We placed the lma in the patient's throat, no air could get by to properly seal the patient's airway because of the broken plastic.Medical intervention was required when the lma would not seal, and the patient's airway was compromised.The patient's airway was not stable with the medications given and the non-functioning lma.It was not until another lma was placed that it was able to inflate and seal the airway allowing our anesthesia machine to breathe for the patient.During this time the patient was deprived of oxygen.The oxygen level was brought back when the other lma was placed.The patient is great, the surgery went normally with a different #4 lma.

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Manufacturer Narrative

(b)(4).The complaint sample received related to "broken/cracked while in use".In reviewing the complaint sample the connector was detached from the airway tube.The outer profile of the returned complaint samples looks yellowish/discolored due to multiple reuses.On the pilot balloon it was observed that the plastic piece on the bottom of the lma #4 that attaches to the syringe to inflate is broken and found the check valve to control air in and out was broken.By using a syringe, attempts were made to inflate/deflate the cuff.Each condition failed due to the broken valve.The complaint was related to user handling or unintentional user error.Potentially the valve was broken due to the handling of the device during insertion of the syringe to the pilot balloon check valve.The device has been used multiple times previously by the appearance of the outer profile of the device being yellowish.No complaint was reported previously related to the same failure mode.No corrective actions required.

Event Description

Reported issue: the plastic piece on the bottom of the lma #4 that attaches to the syringe to inflate is broken and will not allow the air to pass.We placed the lma in the patient's throat, no air could get by to properly seal the patient's airway because of the broken plastic.Medical intervention was required when the lma would not seal, and the patient's airway was compromised.The patient's airway was not stable with the medications given and the non-functioning lma.It was not until another lma was placed that it was able to inflate and seal the airway allowing our anesthesia machine to breathe for the patient.During this time the patient was deprived of oxygen.The oxygen level was brought back when the other lma was placed.The patient is great, the surgery went normally with a different #4 lma.

• Brand Name: LMA FLEXIBLEE SIZE 4
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16079278
• MDR Text Key: 306447966
• Report Number: 3011137372-2022-00256
• 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: 12/15/2022

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: IPN922880
• Device Catalogue Number: 110040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 03/06/2023
• Supplement Dates FDA Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED
• Patient Outcome(s): Life Threatening; Required Intervention