• 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
Lot Number 1806700165
Device Problem Leak/Splash (1354)
Patient Problems Vomiting (2144); Irritability (2421)
Event Date 07/29/2018
Event Type  malfunction  
Event Description
Male infant delivered. Thick meconium noted at delivery. Admitted to nicu for respiratory distress, cyanosis and high risk of infection. Coviden argyle umbilical venous catheter (uvc) 5fr, single lumen, 25cm placed after birth. Skin cleaned with chlorhexidine. Uvc initially secured at 13cm but after x-ray, pulled back to 11cm. Secured with suture. Two days after insertion, the infant had an episode of spitting up and became irritable. During this event, the nurse noted blood backing up in the uvc line. Then the rn noted that the catheter was leaking. The uvc was removed. No injury noted to the patient. Uvc: argyle 5 fr. , 25cm, single lumen.
 
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 Key7893219
MDR Text Key120861022
Report Number7893219
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
Type of Report Initial
Report Date 09/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number1806700165
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/06/2018
Event Location Hospital
Date Report to Manufacturer09/20/2018
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

-
-