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

MAUDE Adverse Event Report: CARDINAL HEALTH, INC. ARGYLE CATHETER, UMBILICAL ARTERY

  • 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
 

CARDINAL HEALTH, INC. ARGYLE CATHETER, UMBILICAL ARTERY Back to Search Results
Model Number 8888160531
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 04/05/2021
Event Type  Injury  
Event Description
While suturing a umbilical catheter argyle" vessel 3. 5 fr. 15 inch dual lumen, it inadvertently broke at 8 cm and was unable to be retrieved. A chest x-ray was immediately taken and the line fragment was in the inferior vena cava. The newborn patient was transferred via lifeflight to a children's specialty hospital. The newborn patient was taken to interventional radiology where they were able to retrieve the fragment from the left pulmonary artery.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARGYLE
Type of DeviceCATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
CARDINAL HEALTH, INC.
3651 birchwood drive
waukegan IL 60085
MDR Report Key11684776
MDR Text Key246027380
Report Number11684776
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160531
Device Catalogue Number8888160531
Device Lot Number2011900052
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/06/2021
Event Location Hospital
Date Report to Manufacturer04/19/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/19/2021 Patient Sequence Number: 1
-
-