MAUDE Adverse Event Report: C.R. BARD, INC. BARD; HICKMAN

Device Problems Crack (1135); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Therapeutic Response, Decreased (2271); Anxiety (2328); No Code Available (3191)

Event Date 01/27/2016

Event Type  Injury  

Event Description

Patient with triple lumen permanent venous access device.During routine cap change with flushing.It was identified the line had a pin hole where the catheter meets the hub.

• Brand Name: BARD
• Type of Device: HICKMAN
• Manufacturer (Section D): C.R. BARD, INC.; 730 central ave. ; corporte office; murray hill NJ 07974
• MDR Report Key: 5450353
• MDR Text Key: 38772320
• Report Number: 5450353
• Device Sequence Number: 1
• Product Code: LJS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/04/2016
• Distributor Facility Aware Date: 01/19/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR