MAUDE Adverse Event Report: C. R. BARD INC.; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 12/22/2020

Event Type  malfunction  

Event Description

Patient power port accessed with 22g 1.0" needle.Patients shirt wet, leaking at lower end of needle tubing (hub).

• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C. R. BARD INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 11086934
• MDR Text Key: 224106010
• Report Number: 11086934
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/22/2020

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: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1