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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LLC ARGYLE UMBILICAL VESSEL CATHETER

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COVIDIEN LLC ARGYLE UMBILICAL VESSEL CATHETER Back to Search Results
Model Number 888816033
Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Information (3190)
Event Date 05/17/2017
Event Type  malfunction  
Event Description
The umbilical artery catheter (uac) was noted to be spontaneously leaking at the distal portion of the thinnest part of the catheter, prior to the hub. The leakage was noted after a fluid change. The line was not pinched or clamped at all prior to leaking. It was later found that the prior rn had bent the line back upon itself, which led to a micro crack. Per rn, packaging of this product states that it should not be bent; so i understand that use error contributed to this leak; but i have submitted this report to indicate the difficulty with using this delicate product. The rn manager also told me that the rns occasionally have difficulty unattaching iv tubing from the uac, and cannot use traditional methods to get it unattached because of the delicacy of the catheter.
 
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Brand NameARGYLE
Type of DeviceUMBILICAL VESSEL CATHETER
Manufacturer (Section D)
COVIDIEN LLC
15 hampshire street
mansfield MA 02048
MDR Report Key6649669
MDR Text Key77842910
Report Number6649669
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
Type of Report Initial
Report Date 06/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model Number888816033
Device Catalogue Number888816033
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/05/2017
Event Location Hospital
Date Report to Manufacturer06/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/19/2017 Patient Sequence Number: 1
Treatment
IV FLUID GIVEN THROUGH IT WITH AN IV PUMP
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