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

Model Number 0142075

Device Problems Break (1069); Fluid/Blood Leak (1250); Material Rupture (1546)

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

Event Date 12/10/2019

Event Type  malfunction  

Event Description

Patient had port tubing break again ~24 hrs after being admitted.This time chemo was infusing.Parents noticed a drop of methotrexate chemo and notified a nurse.Nurse stopped chemo.According to nurses, tubing broke above needleless connector.I believe this is the same place it has broken multiple times in the past.Patient had to be de-accessed, re-accessed, blood cultures were drawn.Remainder of chemo tubing was sent back to pharmacy and i believe placed in a new bag and restarted later that day.This is maybe the 5th time this has happened.I don't think there's been any change.The day before, when the patient was admitted this rn notified the bedside rn about her experiences with the patient's port.Unfortunately it was a very busy day.Not sure how the port was taped or if it was taped any differently.I was not providing direct care to patient.(last time, i notified bedside rn on admission too since i happened to be tl for the day and saw the patient was there).The next day i happened to walk by right when her port needle had broken, so told the nurse for that day that this has happened before.Seems like there has not been any change and this happens to the patient every time she is admitted.I don't think there is an issue with the port needle tubing itself, i think the patient is so active the tubing gets pulled/twisted on too much in the same place every time and it just breaks.Some form of communication needs to be given to the nurses that it has to be dressed/secured a different way or this will continue to happen and something else needs to be done.While filing this report i realized the patient had to be re-accessed two more times.Once the day after the needle came out and it infiltrated, according to parents, and again two days later it broke.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: 10000337
• MDR Text Key: 189011841
• Report Number: 10000337
• 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
• 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: 730 DA