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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH, INC. ARGYLE PICC SINGLE LUMEN CATHETER,INTRAVASCULAR,THERAPEUTIC

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CARDINAL HEALTH, INC. ARGYLE PICC SINGLE LUMEN CATHETER,INTRAVASCULAR,THERAPEUTIC Back to Search Results
Model Number 43303
Device Problem Migration (4003)
Patient Problems Extravasation (1842); Phlebitis (2004)
Event Date 05/25/2019
Event Type  malfunction  
Event Description
5 days after insertion, patient's left leg was infiltrated, swollen, hardened with phlebitis. Our facility has had multiple events with this device and is submitting several reports. The providers were consulted and based upon their assessment, no infection control concerns were identified, and infectious disease was not consulted. It was decided, out of an abundance of caution, to remove the lines. We have not identified a common denominator; therefore, though it might be a device/product concern. The devices have not been returned to the manufacturer at this time. None of the involved patients have required additional medical treatment, like antibiotics, because of their reaction and no cultures were sent. Our clinical team is aware of this concern and are diligently monitoring picc line patients. No additional cases have been identified.
 
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Brand NameARGYLE PICC SINGLE LUMEN
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC
Manufacturer (Section D)
CARDINAL HEALTH, INC.
300 south riverside plaza
suite 2010
chicago IL 60606
MDR Report Key8910399
MDR Text Key154884658
Report Number8910399
Device Sequence Number1
Product Code FOZ
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 07/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model Number43303
Device Catalogue Number43303
Device Lot Number1817200097
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/19/2019
Event Location No Information
Date Report to Manufacturer08/20/2019
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/20/2019 Patient Sequence Number: 1
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