PLEURAVAC PLEURX DRAINAGE SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-02 for PLEURAVAC PLEURX DRAINAGE SYSTEM manufactured by Bd / Carefusion.

Event Text Entries

[113281918] Rn made a skilled visit for the purpose of attempting to drain the pt's pleurx catheter drainage system. In the process of attaching the cannister attachment, the pigtail tubing coming out of the pt broke off. The rn noted that there was bloody drainage in the tubing that looked like it had clotted off. He tied it off, called the dr, and changed the dressing at the insertion site on the pt's chest. Since the pt was not having any increased shortness of breath, the physician was not concerned. According to the home health agency, who cared for the pt prior to hospice caring for the pt (as of (b)(6) 2018), there had been minimal amounts of fluid draining from the system over the past 2 months. Instructions were provided to the assisted living staff to notify the hospice personnel if the dressing came off of the insertion site. The hospice nurse will provide dressing changes 2 times per week to prevent infection to the site. Prior to hospice care, the home health team had utilized the pleurx drainage system intermittently. The nurse had obtained minimal amounts of fluid from the pt's pleural space.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5078224
• MDR Report Key: 7658556
• Date Received: 2018-07-02
• Date of Report: 2018-06-21
• Date of Event: 2018-06-20
• Date Added to Maude: 2018-07-03
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: PLEURAVAC PLEURX DRAINAGE SYSTEM
• Generic Name: PLEURAX PERITONEAL CATHETER SYSTEM
• Product Code: PNG
• Date Received: 2018-07-02
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BD / CAREFUSION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2018-07-02