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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MANUFACTURING SOLUTIONS SA UMBILICAL VESSEL CATHETER CATHETER, UMBILICAL ARTERY

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COVIDIEN MANUFACTURING SOLUTIONS SA UMBILICAL VESSEL CATHETER CATHETER, UMBILICAL ARTERY Back to Search Results
Model Number 888160333
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 06/08/2018
Event Type  Injury  
Event Description
The uvc line was pulled back from 6. 75 to 4 cm due to concern on x-ray that the line was in an unfavorable position. When pulling line back, there was backup of blood in the catheter that was leaking onto the baby's diaper. Upon examination, it was noted that the catheter had been severed in half due to an unknown cause. The remainder of the line was able to be retrieved. Lab work was ordered to rule out infection. A new line was placed to administer iv nutrition. Iv antibiotics were ordered prophylactically.
 
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Brand NameUMBILICAL VESSEL CATHETER
Type of DeviceCATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
COVIDIEN MANUFACTURING SOLUTIONS SA
15 hampshire st
mansfield, MA 02048
MDR Report Key7734971
MDR Text Key115556714
Report Number7734971
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 07/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number888160333
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/03/2018
Event Location Hospital
Date Report to Manufacturer07/31/2018
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?
Type of Device Usage

Patient Treatment Data
Date Received: 07/31/2018 Patient Sequence Number: 1
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