MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROSEAL, REU, SIZE 5 (150050)

Catalog Number 15150

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Date 10/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: "cuff breakage detected when applying lubrication.Record card was not returned from the facility.No information on how many times they have used before the alleged event.Dried lubrication on the product." no patient involvement.Issue detected prior to use.

Event Description

The complaint is reported as: "cuff breakage detected when applying lubrication.Record card was not returned from the facility.No information on how many times they have used before the alleged event.Dried lubrication on the product.".No patient involvement.Issue detected prior to use.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the cuff was torn.The device was unable to hold air due to the tear.Upon closer examination there were dent marks/scratch lines that extended from the failure location.The red plug vent was found to be functional.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint was confirmed.The device was most likely punctured/cut inadvertently due to handling by the user.

• Brand Name: LMA PROSEAL, REU, SIZE 5 (150050)
• Type of Device: LMA PROSEAL
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 9528317
• MDR Text Key: 182600476
• Report Number: 9681900-2019-00056
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

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: 02/26/2023
• Device Catalogue Number: 15150
• Device Lot Number: MFADSB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/28/2019
• Supplement Dates Manufacturer Received: 01/21/2020
• Supplement Dates FDA Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1