Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK MEDICAL AUROUS CENTIMETER SIZING CATHETER; INTRAVASCULAR DIAGNOSTIC 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
 

COOK MEDICAL AUROUS CENTIMETER SIZING CATHETER; INTRAVASCULAR DIAGNOSTIC CATHETER Back to Search Results
Model Number G11916
Device Problems Air Leak (1008); Crack (1135); Fluid/Blood Leak (1250)
Patient Problem No Code Available (3191)
Event Date 06/19/2017
Event Type  malfunction  
Event Description
Patient safety report stated: cracked hub that luer locks causing air to enter catheter when injecting.Medsun report stated: hub of catheter where syringe connects was found to have crack causing air to be drawn into the syringe on aspiration and fluid to leak out during instillation.Manufacturer response for catheter, (brand not provided) (per site reporter): i spoke to a representative and he is sending me a shipping label.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AUROUS CENTIMETER SIZING CATHETER
Type of Device
INTRAVASCULAR DIAGNOSTIC CATHETER
Manufacturer (Section D)
COOK MEDICAL
750 daniels way
bloomington IN 47404
MDR Report Key6680378
MDR Text Key78821353
Report Number6680378
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date10/05/2019
Device Model NumberG11916
Device Catalogue NumberN5.0-35-100-P-10S-PIG-CSC-20
Device Lot Number7307477
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/26/2017
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer06/26/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
SYRINGE IS CONNECTED TO THE CATHETER FOR INJECTING
Patient Age59 YR
-
-