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

Model Number 0142075

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/26/2020

Event Type  malfunction  

Event Description

Rn went in to perform dressing change that was soiled.Rn noticed once dressing was removed that plastic port piece (where the needle is) had moisture in it.Rn then deaccessed patient and saved port for educator.The port needle set for implanted central venous catheters (cvc's) failed--the tubing ruptured where it inserts the hard plastic cap.The device leaked and was opened to air.It put the patient at risk for bleeding, an air embolus and/or infection.

• Brand Name: PORT ACCESS NEEDLE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 10008792
• MDR Text Key: 189303827
• Report Number: 10008792
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0142075
• Device Catalogue Number: 0142075
• Device Lot Number: ASDUF021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 365 DA