MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SIZE 5; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 125050

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint alleges the device folded over during patient use.The device was replaced with a new one with no further issue reported.It was reported there was no patient injury or harm.

Manufacturer Narrative

Qn#(b)(4).The sample was not returned; however, the customer did provide a photo for evaluation.Upon review of the photo it was observed that the airway tube was observed to have been cut.It could not be determined from the photo if the cut was related to the issue reported by the customer.Complaint verification testing could not be performed as the actual sample was not 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 device folded over during patient use.The device was replaced with a new one with no further issue reported.It was reported there was no patient injury or harm.

• Brand Name: LMA UNIQUE SIZE 5
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 8338806
• MDR Text Key: 136146748
• Report Number: 9681900-2019-00002
• 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: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/28/2021
• Device Catalogue Number: 125050
• Device Lot Number: NMBC3G
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2019
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.