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

Model Number	011901NY
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of coronary artery disease, lung cancer and coronary obstruction pulmonary disease.While receiving outpatient chemotherapy, it was attempted to access patient port.When the port kit was opened, needle was collapsed with no sheath covering needle.The needle was unable to be used.No known harm.

• 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: 11138924
• Report Number: 11138924
• Device Sequence Number: 2946943
• Product Code: FPA
• UDI-Device Identifier: 00801741065484
• UDI-Public: (01)00801741065484(17)221231(10)REEN1817
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/06/2021
• Report Date (Section F): 01/06/2021

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: 011901NY
• Device Catalogue Number: 011901NY
• Device Lot Number: REEN1817
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2021
• Patient Sequence Number: 1
• Patient Weight: 84
• Date Report Sent to FDA: 01/06/2021