MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. UNKNOWN; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number 0736073/1502R

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2019

Event Type  malfunction  

Event Description

Crrt through line.Line inserted to hub and sutured.Line came out during crrt securement wing when catheter hubbed and heavy weight of crrt circuit may be contributing factors.

• Brand Name: UNKNOWN
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 8398865
• MDR Text Key: 138102130
• Report Number: 8398865
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0736073/1502R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/11/2019
• Date Report to Manufacturer: 03/07/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20075 DA