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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH, INC. ARGYLE; CATHETER, UMBILICAL ARTERY
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CARDINAL HEALTH, INC. ARGYLE; CATHETER, UMBILICAL ARTERY Back to Search Results
Model Number 8888160432
Device Problems Backflow (1064); Crack (1135); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/29/2019
Event Type  malfunction  
Event Description
Umbilical artery catheter placed in infant.Ivfs attached and transducing appropriate waveform and bp.Lab drawn from uac at stopcock connection without incidence.Good blood return.Flushed easily.Approximately 20 minutes later, line began to back up blood and noted leaking from a crack in line near hub.Line clamped to prevent blood loss.Md notified.Catheter removed by md and replaced with new umbilical catheter.Catheter saved for evaluation.
 
Event Description
Umbilical artery catheter placed in infant.Ivfs attached and transducing appropriate waveform and bp.Lab drawn from uac at stopcock connection without incidence.Good blood return.Flushed easily.Approximately 20 minutes later, line began to back up blood and noted leaking from a crack in line near hub.Line clamped to prevent blood loss.Md notified.Catheter removed by md and replaced with new umbilical catheter.Catheter saved for evaluation.
 
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Brand Name
ARGYLE
Type of Device
CATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
CARDINAL HEALTH, INC.
7000 cardinal place
dublin OH 43017
MDR Report Key8640018
MDR Text Key146067591
Report Number8640018
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 05/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2019
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number8888160432
Device Catalogue Number8888160432
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/16/2019
Event Location Hospital
Date Report to Manufacturer05/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age1 DA
Patient Weight2
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