MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. BROVIAC 4.2 F SINGLE-LUMEN CV CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 0600520

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 02/22/2023

Event Type  malfunction  

Event Description

During routine line assessment, blood was noted to be on the patient's gown.Bleeding was noted to be originating from a part of the line that is more distal from the patient.It was discovered that there was a crack on the line and was due to clamping the line inappropriately.

• Brand Name: BROVIAC 4.2 F SINGLE-LUMEN CV CATHETER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 16627219
• MDR Text Key: 312127115
• Report Number: 16627219
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/17/2023,03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0600520
• Device Catalogue Number: 0600520
• 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: 03/17/2023
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 300 DA
• Patient Sex: Male
• Patient Weight: 10 KG
• Patient Ethnicity: Hispanic