Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP 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
 

COVIDIEN LP ARGYLE; CATHETER, UMBILICAL, ARTERY Back to Search Results
Model Number 8888160341
Device Problems Leak/Splash (1354); Material Integrity Problem (2978); Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/14/2017
Event Type  malfunction  
Event Description
The uac was found to be leaking at the junction of the tubing and hub.Bedside nurse stated "it looks like a tear from where people kink it off for fluid changes." this is the second leaking uac we have had internally reported in the last four months, also at the same place.This seems to be a weakness in the device because staff clamps or kinks the line to occlude flow when changing fluids.Because of the leak, the line had to be removed and a new device re-inserted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ARGYLE
Type of Device
CATHETER, UMBILICAL, ARTERY
Manufacturer (Section D)
COVIDIEN LP
15 hampshire st.
mansfield MA 02048
MDR Report Key6510820
MDR Text Key73349252
Report Number6510820
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 Other
Type of Report Initial
Report Date 03/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number8888160341
Device Catalogue Number8888160341
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/31/2017
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer03/31/2017
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
Patient Outcome(s) Other;
-
-