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

Model Number	0682010
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Early 70¿s female with history of ovarian cancer.Procedure: infusion therapy.Miniloc tubing has 2 ports.The port closest to the needle has a hard cap.While the patient was in the physician¿s office, the hard cap was observed off and blood was coming out of it onto the patient's shirt.The port needle was removed without known harm to patient.It is unclear how the screw cap came off.

• 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: 16310844
• Report Number: 16310844
• Device Sequence Number: 6767335
• Product Code: FPA
• UDI-Device Identifier: 00801741048029
• UDI-Public: (01)00801741048029(17)250804(10)ASGVFCO14
• 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): 01/19/2023
• Report Date (Section F): 01/19/2023

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
• Device Model Number: 0682010
• Device Catalogue Number: 0682010
• Device Lot Number: ASGVFCO14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 62 KG
• Date Report Sent to FDA: 01/19/2023