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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. PORT ACCESS NEEDLE SET, ADMINISTRATION, INTRAVASCULAR
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BARD ACCESS SYSTEMS, INC. PORT ACCESS NEEDLE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 0652034
Device Problems Nonstandard Device (1420); Retraction Problem (1536)
Patient Problem Needle Stick/Puncture (2462)
Event Date 07/11/2019
Event Type  malfunction  
Event Description
The patient's power port was due to be flushed and de-accessed after completing a ct scan. The nurse put on gloves and removed the dressing. The port needle was retracted in typical fashion, the safety mechanism failed to hold the needle in place and the needle penetrated the nurse's right index finger. The nurse washed her hands with hot water and soap and forced bleeding from her finger. The nursing manager was notified of the needle stick and the occupational nurse was also notified. Needle packaging was given to nurse manager. Manufacturer response for set, administration, intravascular, port access needle (per site reporter); our materials management team will alert the vendor. There was a recall on this product (not sure of the exact lots), but the lots of this product have been removed from our shelves in all radiology areas.
 
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Brand NamePORT ACCESS NEEDLE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city UT 84116
MDR Report Key8850395
MDR Text Key152951516
Report Number8850395
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/01/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0652034
Device Catalogue Number0652034
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/17/2019
Event Location Hospital
Date Report to Manufacturer08/01/2019
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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