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

Model Number	0632210
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Infant pediatric patient accessed with a port-a-cath (pac) needle.Iv pump alarming downstream occlusion throughout the shift.The pac safety needle was retracting out of port, requiring reinforcement of the needle underneath the dressing.This was causing stress and pain for the patient.

• 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: 8486275
• Report Number: 8486275
• Device Sequence Number: 11237802
• Product Code: FPA
• UDI-Device Identifier: 00801741047589
• UDI-Public: (01)00801741047589
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2019
• Report Date (Section F): 03/27/2019

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: 0632210
• Device Catalogue Number: 0632210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/05/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/27/2019