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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP ARGYLE; CATHETER, UMBILICAL ARTERY
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COVIDIEN LP ARGYLE; CATHETER, UMBILICAL ARTERY Back to Search Results
Model Number 8888160432
Device Problem Hole In Material (1293)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/08/2018
Event Type  malfunction  
Event Description
While caring for the pre-term infant, the registered nurse (rn) noted the umbilical venous catheter (uvc) that was in place had a hole in the catheter.She stated she was checking in on the infant when she noticed that the diaper was wet.Upon closer examination, she noticed fluid leaking from a hole in the line.The hole was located near the umbilical site, maybe 1/2 cm from the umbilical.The line had been pulled back 3 cm about 30 minutes prior.When questioned whether the defect was located anywhere near the suture site, the rn stated "no." there were no clamps in use at the time and the rn denied that the catheter was kinked.The neonatal nurse practitioner was alerted to the issue, and the catheter was removed.Catheter information: 5fr., single lumen argyle uvc.
 
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Brand Name
ARGYLE
Type of Device
CATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
COVIDIEN LP
15 hampshire st.
mansfield MA 02048
MDR Report Key7247215
MDR Text Key99212303
Report Number7247215
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/25/2018,02/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number8888160432
Device Catalogue Number8888160432
Device Lot Number1713000079
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/25/2018
Event Location Hospital
Date Report to Manufacturer01/25/2018
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
NOT KNOWN.; THE PATIENT IS AN INFANT, DELIVERED PRE-TERM AT (B)(6)
Patient Weight1
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