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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS, INC. CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Device Problem Material Perforation (2205)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/09/2017
Event Type  malfunction  
Event Description
While attempting to insert a peripheral iv, the iv needle went through the side wall of the catheter. A new iv was obtained and established without incident. No harm to the patient.
 
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Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city UT 84116
MDR Report Key7009281
MDR Text Key91358626
Report Number7009281
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 10/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/16/2017
Event Location Hospital
Date Report to Manufacturer10/16/2017
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: 11/08/2017 Patient Sequence Number: 1
Treatment
NONE KNOWN.
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