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

Model Number 1608062

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pleural Effusion (2010)

Event Date 10/21/2022

Event Type  malfunction  

Event Description

Suspected pleural effusion from chemotherapy access.Fda safety report id #(b)(4).

• Brand Name: CLEARVUE INFUSAPORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC.
• MDR Report Key: 15744108
• MDR Text Key: 303335345
• Report Number: MW5113092
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026430
• UDI-Public: 00801741026430
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/02/2022

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 Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 1608062
• Device Catalogue Number: 1608062
• Device Lot Number: REGT1276
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/04/2022
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 62 KG