MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. SAFESTEP; NON-CORING (HUBER) NEEDLE

Model Number	CPA00019B
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Used a kit to access patient port and chlorhexidine did not release into sponge.This is the third kit i have had problems with chlorhexidine not releasing into sponges over the past 1 week.

• Brand Name: SAFESTEP
• Common Device Name: NON-CORING (HUBER) NEEDLE
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 11769100
• Report Number: 11769100
• Device Sequence Number: 19833218
• Product Code: PTI
• UDI-Device Identifier: 00801741153280
• UDI-Public: (01)00801741153280(17)220331
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/22/2021
• Report Date (Section F): 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CPA00019B
• Device Catalogue Number: CPA00019B
• Device Lot Number: REFN0814
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 05/04/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2021
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/22/2021