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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC. CENTRAL CATHETER CATHETER, INTRAVASCULAR

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COOK INC. CENTRAL CATHETER CATHETER, INTRAVASCULAR Back to Search Results
Device Problem Leak/Splash (1354)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 10/07/2018
Event Type  Injury  
Event Description
Right femoral line placed (b)(6) 2018 developed a leak on day four of use ((b)(6) 2018). Triple lumen 5fr 8cm catheter (manufactured by cook) with leak on blue port of line. This is the second time for this pt this failure mode had occurred, and similar product by the same mfr. This port is locked and out of use, however the line is still in placed as the other two ports are being used for cares. Not having the third port impacts, the care for this pt and may require the pt to have add'l access created.
 
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Brand NameCENTRAL CATHETER
Type of DeviceCATHETER, INTRAVASCULAR
Manufacturer (Section D)
COOK INC.
MDR Report Key7957307
MDR Text Key123517863
Report NumberMW5080495
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 10/08/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received10/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/10/2018 Patient Sequence Number: 1
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