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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 Break (1069); Crack (1135); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/21/2020
Event Type  malfunction  
Event Description
Umbilical vessel catheter (uvc) placed on infant following delivery. No insertion complications noted. The procedure note reported blood was withdrawn easily and the catheter flushed without difficulty. Imaging showed the placement in the right hepatic lobe. Repositioning was needed. Staff report the catheter broken after being "pulled back to a low-lying line. " per the procedure note, after insertion the catheter noted to be cracked at the hub, but upon further assessment staff noted the catheter was split in half with only the radiopaque line holding it together. The uvc was removed. Argyle 5fr. Uvc (polyurethane catheter). Secured with suture at 11cm. Dwell time: less than 10 minutes. Manufacturer response for vascular, argyle (per site reporter). Yes, representative is aware and investigating. Informed that catheter is available to return. At the time of this report, it is unknown to this writer if catheter has been returned.
 
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Brand NameARGYLE
Type of DeviceCATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
CARDINAL HEALTH, INC.
300 south riverside plaza
chicago IL 60606
MDR Report Key9670483
MDR Text Key177799151
Report Number9670483
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number8888160432
Device Catalogue Number8888160432
Device Lot Number1906400173
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/03/2020
Event Location Hospital
Date Report to Manufacturer02/05/2020
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

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