MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERPORT DUO M.R.I. IMPLANTABLE PORT KITS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 5829502

Device Problems Nonstandard Device (1420); Defective Device (2588)

Patient Problem Bruise/Contusion (1754)

Event Date 03/25/2021

Event Type  Injury  

Event Description

Bard powerport duo m.R.I.Implantable port (recall on multiple lots, received by our hospital late on 3/25/2021).This patient is a (b)(6) man with a past medical history of squamous cell carcinoma, basal cell carcinoma, atrial fibrilation, and a recent diagnosis of anaplastic cd30+ alk-large cell lymphoma requiring longer term central venous access for blood draws and treatment administration.On (b)(6) 2021, the pt underwent an interventional radiology (ir) procedure for placement of a double lumen chest port for the purpose of his treatment ( bard powerport duo m.R.I.Implantable port (lot#reev2356).Within 1-2 weeks, difficulties with one of the two lumens was reported, the port would rise when flushed and there was bruising noted around the site; the port was assessed by ir, determined that the pt.Required a new port, and was scheduled for a port replacement on (b)(6) 2021.When this port was removed, it was noted to be defective.The port was replaced with another bard device (lot#reev2356).Later on this day we received the medical device product recall from bard access systems, inc.Unfortunately the port/ device that was replaced in this patient was also a device that we later found out was also recalled.The patient is scheduled for port removal and replacement on (b)(6) 2021.Additional information: all inventory of recalled products were removed and destroyed.A notification was sent out to appropriate clinical staff regarding the recall that we were investigating (to determine which patients were affected).And informed them of extra precautions to take to identify any implantable ports where there may be concerns.In total, there were 20 patients who had these recalled ports implanted within them when we received the recall notification from bard.All of the patient's attending mds were immediately notified; the patients affected were notified by their mds and then a follow-up letter/ notification was mailed to each patient with information.At the time of this reporting, several patients have had peripherally inserted central catheters (piccs) inserted so that there would be no interruption in their treatment while the patients are awaiting interventional radiology procedures to have the ports removed (and replaced); 12 patients remain which ports implanted, who will have these removed and replaced in interventional radiology.Of note, for ports to be removed or replaced, a patient must undergo an invasive procedure that requires anesthesia.There have been no adverse outcomes reported at this time from this process nor any treatments that have been delayed.We will continue to monitor for adverse outcomes.Fda safety report id# (b)(4).

• Brand Name: POWERPORT DUO M.R.I. IMPLANTABLE PORT KITS
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 11669436
• MDR Text Key: 245790860
• Report Number: MW5100777
• Device Sequence Number: 1
• Product Code: LJT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/13/2021

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: Health Professional
• Device Catalogue Number: 5829502
• Device Lot Number: REEV2356
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/14/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 129