MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROTECTOR CUFF PILOT SIZE 3; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 192030

Device Problem Deflation Problem (1149)

Patient Problem No Patient Involvement (2645)

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint alleges "the user was not able to deaerate from the cuff with a syringe during inflation test prior to use on a patient." a new device was used instead.No patient involvement was reported.

Event Description

Customer complaint alleges "the user was not able to deaerate from the cuff with a syringe during inflation test prior to use on a patient." a new device was used instead.No patient involvement was reported.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.The sample was received with the syringe.A visual exam was performed and no defects were observed.The sample was then subjected to a cuff leak test with two different types of syringes (the syringe that was returned with the device and a manufacturing syringe).The cuff was able to inflate and deflate; however, slight force was needed to insert the syringe into the cuff pilot valve.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 could not be confirmed.There were no issues found with the returned device.The device was found to be functional.

• Brand Name: LMA PROTECTOR CUFF PILOT SIZE 3
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 8124517
• MDR Text Key: 129449429
• Report Number: 9681900-2018-00043
• 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
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/28/2020
• Device Catalogue Number: 192030
• Device Lot Number: MMBV8P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Initial Date Manufacturer Received: 11/09/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 12/17/2018
• Supplement Dates FDA Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SYRINGE (NO FURTHER DETAILS); SYRINGE (NO FURTHER DETAILS)