MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERPORT CLEARVUE; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number LAB0729634

Device Problem Flushing Problem (1252)

Patient Problem Insufficient Information (4580)

Event Date 02/11/2022

Event Type  malfunction  

Event Description

Port was placed into patient and would not flush.

• Brand Name: POWERPORT CLEARVUE
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 13590783
• MDR Text Key: 286059114
• Report Number: 13590783
• Device Sequence Number: 1
• Product Code: LJT
• 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: 02/15/2022

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 Model Number: LAB0729634
• Device Lot Number: REFW5078
• 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: 02/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Sex: Female