MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. PORT ACCESS NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	0652234
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Powerloc infusion set would not flush properly when priming.

• Brand Name: PORT ACCESS NEEDLE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 7094937
• Report Number: 7094937
• Device Sequence Number: 782510
• Product Code: FPA
• UDI-Device Identifier: 00801741047794
• UDI-Public: (01)00801741047794(17)181028(10)ASBSS0147
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 12/05/2017
• Report Date (Section F): 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Expiration Date: 10/28/2018
• Device Model Number: 0652234
• Device Catalogue Number: 0652234
• Device Lot Number: ASBSS0147
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Weight: 18
• Date Report Sent to FDA: 12/05/2017