MAUDE Adverse Event Report: C.R. BARD, INC. CORPORATE OFFICES BARD; CENTRAL LINE

Model Number NOT AVAILABLE

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 10/09/2015

Event Type  Injury  

Event Description

Pt's triple lumen catheter (blue lumen) began leaking from a pin point hole while being flushed with normal saline by the clinical staff member.

• Brand Name: BARD
• Type of Device: CENTRAL LINE
• Manufacturer (Section D): C.R. BARD, INC. CORPORATE OFFICES; 730 central avenue; murray hill NJ 07974
• MDR Report Key: 5246107
• MDR Text Key: 32154893
• Report Number: 5246107
• Device Sequence Number: 1
• Product Code: OFF
• 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: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: NOT AVAILABLE
• Device Catalogue Number: NOT AVAILABLE
• Device Lot Number: NOT AVAILABLE
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/13/2015
• Distributor Facility Aware Date: 10/09/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2015
• 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: 67 YR
• Patient Weight: 100