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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. BARD POWER PICC LINE CATHTER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

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BARD ACCESS SYSTEMS, INC. BARD POWER PICC LINE CATHTER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Lot Number CK000452
Device Problem Material Fragmentation (1261)
Patient Problem No Code Available (3191)
Event Date 07/25/2019
Event Type  Injury  
Event Description
Retained picc line fragment in right ventricle of heart. Patient taken to interventional radiology for image guided retrieval of foreign body. Fda safety report id # (b)(4).
 
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Brand NameBARD POWER PICC LINE
Type of DeviceCATHTER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
salt lake city UT 84116
MDR Report Key9086991
MDR Text Key159373604
Report NumberMW5089898
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 Risk Manager
Type of Report Initial
Report Date 09/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/30/2019
Device Lot NumberCK000452
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?
Type of Device Usage

Patient Treatment Data
Date Received: 09/18/2019 Patient Sequence Number: 1
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