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

Model Number	PA-0031
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	08/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Patient arrived for chemo disconnect, noticed white powder type substance/residue on port extension and patient's chest/breast area.Substance appeared to be crystalized 5 fu chemo.When port was flushed with ns and heparin, it leaked via the y site valve.Patient called when he arrived home after checking shirt he wore previous day and that also had white residue on it.

• Brand Name: PORT ACCESS KIT
• 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: 9109131
• Report Number: 9109131
• Device Sequence Number: 1782398
• Product Code: FPA
• UDI-Device Identifier: 00801741085529
• UDI-Public: (01)00801741085529
• 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): 09/06/2019
• Report Date (Section F): 09/06/2019

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: PA-0031
• Device Catalogue Number: PA-0031
• Device Lot Number: REDS3003
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 09/24/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 110
• Date Report Sent to FDA: 09/06/2019