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U.S. Department of Health and Human Services

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

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CARDINAL HEALTH, INC. UMBILICAL VENOUS CATHETER CATHETER, UMBILICAL ARTERY Back to Search Results
Lot Number 1807300140
Device Problems Disconnection (1171); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/14/2018
Event Type  malfunction  
Event Description
Attempted flush: rn attempted to flush the uvc #2 distal lumen with heparin and upon pressing the syringe plunger into the distal lumen port, fluid began to be pressed backward through the proximal lumen and leaking out at the bifurcation point of the proximal and distal lumens. Upon retrieval of another nurse and returning to examine the issue, it was discovered that the proximal lumen had snapped and disconnected from the extended line. Uvc fluid stopped, line clamped and then removed. New fluid was started through piv. Tpn/il will run through piv. Insertion: 3 days prior, 5. 0 double french lumen catheter was used. On insertion, the catheter was inserted in the umbilical artery. Secure/sutured umbilical stump in 7cm. The outcomes were advanced easily, blood return obtained and flushed without difficulty. X-ray confirmed placement at t7. Line cleared for use. Staff has no reason why catheter should have malfunctioned.
 
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Brand NameUMBILICAL VENOUS CATHETER
Type of DeviceCATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
CARDINAL HEALTH, INC.
3651 birchwood drive
waukegan IL 60085
MDR Report Key8189177
MDR Text Key131157768
Report Number8189177
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 Risk Manager
Type of Report Initial
Report Date 12/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number1807300140
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/17/2018
Event Location Hospital
Date Report to Manufacturer12/21/2018
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

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