MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA CLASSIC, REU, SIZE 4 (100040); AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 10140

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint alleges the pilot balloon valve ruptured in second use.Alleged defect reported detected prior to use on a patient.No patient harm reported.Patient condition reported as fine.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.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.

Event Description

Customer complaint alleges the pilot balloon valve ruptured in second use.Alleged defect reported detected prior to use on a patient.No patient harm reported.Patient condition reported as fine.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the inflation balloon of the complaint device was damaged.The shape of the balloon looked bigger than it should be.The inflation balloon material lost its resilience due to stress.It is consistent that the inflation balloon was ruptured by air.The check valve of the inflation balloon was found to be functional.There was no blockage on the check valve and air could be inflated and deflated.A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.Based on the investigation performed, the reported complaint was confirmed.Over-inflation is a known cause that leads to inflation balloon rupture.During high temperature, vacuum, and humid autoclaving environment, any air/moisture trapped inside the device will expand significantly and will damage the properties of the device to an irreparable condition.It is suspected that there was some kind of residual air/moisture left in the device while re-processing/handling that cause the failure inadvertently.

Event Description

Customer complaint alleges the pilot balloon valve ruptured in second use.Alleged defect reported detected prior to use on a patient.No patient harm reported.Patient condition reported as fine.

• Brand Name: LMA CLASSIC, REU, SIZE 4 (100040)
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 8127346
• MDR Text Key: 129462647
• Report Number: 9681900-2018-00042
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/02/2022
• Device Catalogue Number: 10140
• Device Lot Number: MFAAD9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.