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U.S. Department of Health and Human Services

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

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BARD ACCESS SYSTEMS, INC. STATLOCK STATLOCK STABILIZATION DEVICE UNIVERSAL PLUS 10-12 F Back to Search Results
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.
 
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Brand NameSTATLOCK
Type of DeviceSTATLOCK 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 Key7214905
MDR Text Key98227771
Report NumberMW5074762
Device Sequence Number1
Product Code FEG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received01/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2020
Device Catalogue NumberVUPD1012
Device Lot NumberJUBWF424
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
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