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

Model Number 0142075

Device Problems Crack (1135); Leak/Splash (1354); Material Rupture (1546)

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

Event Date 12/12/2019

Event Type  malfunction  

Event Description

Port tubing cracked above the blue cap.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: 10000361
• MDR Text Key: 189004380
• Report Number: 10000361
• 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 an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0142075
• Device Catalogue Number: 0142075
• 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: 04/27/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 365 DA