• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC OPTISITE ARTERIAL PERFUSION CANNULA CANNULA, CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

EDWARDS LIFESCIENCES LLC OPTISITE ARTERIAL PERFUSION CANNULA CANNULA, CATHETER Back to Search Results
Lot Number 61338640
Device Problems Leak/Splash (1354); Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/07/2019
Event Type  Injury  
Event Description
Cannula luer cap failed during use and was leaking blood from the cannula. Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOPTISITE ARTERIAL PERFUSION CANNULA
Type of DeviceCANNULA, CATHETER
Manufacturer (Section D)
EDWARDS LIFESCIENCES LLC
irvine CA 92614
MDR Report Key9315977
MDR Text Key166360953
Report NumberMW5091014
Device Sequence Number1
Product Code DQR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 11/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/10/2021
Device Lot Number61338640
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/12/2019 Patient Sequence Number: 1
-
-