MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROSEAL, REU, SIZE 4 (150040); AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 15140

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has not been received by the manufacturer at the time of this report.The investigation into this complaint is still in progress.

Event Description

Customer complaint alleges "lma cuff found to have herniated cuff during pre-op inspection." alleged event reported as occurring prior to use on a patient during inspection/functional testing.There was no report of patient injury or consequence.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the cuff was deformed.The silicone cuff material of the device looks sagged and lost its resilience due to stress.When compared with a retained sample, the shape of the material of the returned sample looked different than the retained sample.The checked valve of the returned device was functional; it could be inflated and deflated.In addition, the red plug vent is free from blockage and air could be released.A device history record (dhr) review was performed and there were no issues found.Air pressure is a known cause that leads to cuff herniation/internal rupture of components of the lma mask.During high temperature, vacuum, and humid environment, and air/moisture left inside the cuff will expand significantly and it will damage the properties of the components to an irreparable condition.It is highly suspected that some residual air/moisture was left inside the device while handling/reprocessing that caused the failure.The cuff must be completely deflated prior to autoclaving.

Event Description

Customer complaint alleges "lma cuff found to have herniated cuff during pre-op inspection." alleged event reported as occurring prior to use on a patient during inspection/functional testing.There was no report of patient injury or consequence.

• Brand Name: LMA PROSEAL, REU, SIZE 4 (150040)
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• 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 ; 9194334854
• MDR Report Key: 7276564
• MDR Text Key: 100512847
• Report Number: 9681900-2018-00014
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K780900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 15140
• Device Lot Number: SN:8VSAHVL4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1