MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA FLEXIBLE SIZE 5; AIRWAY, OROPHARYNGEAL, ANESTH

Model Number IPN922881

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "after 21 uses, arming failure occurred on the straight and extended part crossing".No medical intervention needed.Patient condition reported as "fine".

Manufacturer Narrative

Qn#(b)(4).Lma flexible was returned from czech on ground of "spiral in tube deformed during use".The was record card received stated already used 21 times.A kink was observed in the airway tube.The circular reinforced metal wire was deformed by force and kinked that badly hamper the functionality of the airway tube.Testing on a separate device of the same design, that this can only be achieved if the device has been caught and the tube has subsequently been pulled with significant force.Dhr was reviewed.No abnormality found.The device was probably kinked due to handling (spiral in tube deformed).The circular reinforced metal wire was deformed by force and kinked that badly hampers the functionality of the airway tube.Testing on a separate device of the same design shows that this can only be achieved if the device has been caught and the tube has subsequently been pulled with significant force.

Event Description

It was reported that "after 21 uses, arming failure occurred on the straight and extended part crossing".No medical intervention needed.Patient condition reported as "fine".

• Brand Name: LMA FLEXIBLE SIZE 5
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTH
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16008217
• MDR Text Key: 308377034
• Report Number: 9681900-2022-00035
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: EZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN922881
• Device Catalogue Number: 110050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female