MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. STATLOCK STATLOCK STABILIZATION DEVICE UNIVERSAL PLUS 10-12 F

Catalog Number VUPD1012

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Pleural Effusion (2010); Pressure Sores (2326)

Event Date 12/16/2017

Event Type  Injury  

Event Description

Pt required bilateral chest tube insertion for bilateral pleural effusions on (b)(6) 2017. The pigtail catheters were secured to the skin (using statlock). On (b)(6) 2016, the right chest tube was removed. Under the statlock device, an unstageable pressure injury had developed. Upon removal of the left chest tube, the skin i contact with the statlock was intact. Right and left side thoracentesis via 10 cm #5 french centesis catheter, serial dilation with use of guidewire. Protein caloric malnutrition, massive anasarca, cancer with metastasis to bone and lymph nodes. Pt admit with shortness of breath, then a 12 french pigtail catheter was inserted into pleural space.

• Brand Name: STATLOCK
• Type of Device: STATLOCK STABILIZATION DEVICE UNIVERSAL PLUS 10-12 F
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 87116
• MDR Report Key: 7214905
• MDR Text Key: 98227771
• Report Number: MW5074762
• Device Sequence Number: 1
• Product Code: FEG
• Combination Product (y/n): N
• 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: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/28/2020
• Device Catalogue Number: VUPD1012
• Device Lot Number: JUBWF424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 01/23/2018 Patient Sequence Number: 1