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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. POWER PICC PROVENA CATHETER GUIDE WIRE CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

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C.R. BARD, INC. POWER PICC PROVENA CATHETER GUIDE WIRE CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number CK000909A
Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/13/2020
Event Type  malfunction  
Event Description
During placement of a midline catheter, when inserting the guidewire, the nurse identified resistance and then she attempted to pull the guide wire out and was unable to do so. The tip of the guidewire prevented removal.
 
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Brand NamePOWER PICC PROVENA CATHETER GUIDE WIRE
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
Manufacturer (Section D)
C.R. BARD, INC.
MDR Report Key9971988
MDR Text Key188408962
Report NumberMW5094180
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCK000909A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/16/2020 Patient Sequence Number: 1
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