MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK; CATHETER STABILIZATION DEVICE

Device Problem Device Slipped (1584)

Patient Problems Vascular System (Circulation), Impaired (2572); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Patient says the device does not lock.It closes but does not lock especially when heavy.(design flaw).Patient called manufacturer and was advised to use leg straps.When he does, the leg straps affect the blood circulation to his legs and yet the lock still comes open.So he stopped using the leg straps.( reason why he says it shouldn't be called a 'lock') patient would like to know how far the fda has gone with this complaint.

• Brand Name: STATLOCK
• Type of Device: CATHETER STABILIZATION DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS
• MDR Report Key: 4121961
• MDR Text Key: 4791145
• Report Number: MW5038359
• Device Sequence Number: 1
• Product Code: EYJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR