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

Model Number 1808001

Device Problems Fluid/Blood Leak (1250); Defective Device (2588); Material Split, Cut or Torn (4008)

Patient Problems Tissue Damage (2104); Caustic/Chemical Burns (2549); Chemical Exposure (2570)

Event Date 03/13/2019

Event Type  Injury  

Event Description

On (b)(6) 2019 during a routine folfox chemo infusion, a bard implantable powerport experienced catastrophic catheter failure leaking chemo chemicals into (b)(6)'s left shoulder causing extravasation and resulting in chemical burns to her internal soft tissue in her neck.Please refer to the product info on the pdf document.On (b)(6) 2019, the powerport was surgically removed.On examination, the catheter showed a clean split along the length of the catheter on either side, approx where it entered her vein.Each slit was about an inch long.Her dr showed me the defect and said it leaked about just inside her vein.It is unk how much chemical leaked inside her neck and chest.Upon installing a picc line in her right shoulder on (b)(6) 2019 in order to continue future chemo treatments, her dr told me that it was a product defect.Since the catheter is rated up to 300 psi and ore of the syringes used to flush the port can exceed 200 psi.It is unlikely an over pressure due to the routine operations caused his failure.Her surgeon told me the catheter failure location was not in a bed stress location.This powerport was installed (b)(6) 2017.Pt (b)(6).

• Brand Name: BARD POWERPORT M.R.I. IMPLANTABLE PORT
• Type of Device: PORT AND CATHETER IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 8470803
• MDR Text Key: 140607073
• Report Number: MW5085430
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: 1808001
• Device Catalogue Number: (10)REBN2099
• Device Lot Number: REBN2099
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention; Disability
• Patient Age: 66 YR
• Patient Weight: 64