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

Catalog Number 15140

Device Problem Material Rupture (1546)

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

Event Date 10/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint alleges "back side of lma ruptured.Anesthesiologist noticed when taking out of sterile pack to prep for a case." alleged issue reported as detected prior to use on patient.It was reported there was no patient harm.

Manufacturer Narrative

Qn#: (b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed there was a hole in the cuff.It was also noticed that the cuff showed signs of losing its resilience due to stress at the failure location.The glue line at the joint of the cuff was intact.The check valve was tested and found to be functioning as intended.No blockage was found.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.It is suspected that there was some kind of residual air/moisture that was left inside the device while re-processing/handling that caused the cuff to rupture.During high temperature, vacuum, and humid autoclaving environment, any air/moisture left inside the cuff will expand significantly and it will damage the properties of the device to an irreparable condition.

Event Description

Customer complaint alleges "back side of lma ruptured.Anethesiologist noticed when taking out of sterile pack to prep for a case." alleged issue reported as detected prior to use on patient.It was reported there was no patient harm.

• Brand Name: LMA PROSEAL, REU, SIZE 4 (150040)
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 7985731
• MDR Text Key: 125612056
• Report Number: 9681900-2018-00035
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 15140
• Device Lot Number: SN:8VTAG5BE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Date Manufacturer Received: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.