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

Catalog Number 15140

Device Problem Deflation Problem (1149)

Patient Problem No Patient Involvement (2645)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint alleges the new device would inflate but not deflate prior to inital sterilization.No patient involvement reported with this event.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no physical damage was observed.The device could be inflated and deflated with the check valve normally.It was observed that the deflation was slightly sluggish with deflated with the red plug open; however, with a slight pinch on the sides on the red plug the deflation improved.A device history record 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.The device was functional and could be inflated and deflated using the check valve.The deflation could improve with a slight pinch on the sides of the red plug.This could be due to inevitable expansion and contraction of the components material during logistics movement over time.

Event Description

Customer complaint alleges the new device would inflate but not deflate prior to inital sterilization.No patient involvement reported with this event.

• Brand Name: LMA PROSEAL, REU, SIZE 4 (150040)
• Type of Device: LMA PROSEAL
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 7597805
• MDR Text Key: 111014098
• Report Number: 9681900-2018-00027
• 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: 05/25/2018

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 Catalogue Number: 15140
• Device Lot Number: SN:8VRAT5EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 06/13/2018
• Supplement Dates Manufacturer Received: 07/02/2018
• Supplement Dates FDA Received: 07/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1