MAUDE Adverse Event Report: BD / BARD ACCESS SYSTEMS, INC. POWER PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Device Problem Failure to Advance (2524)

Patient Problems Scar Tissue (2060); Discomfort (2330)

Event Date 03/31/2021

Event Type  Injury  

Event Description

Several experienced people unable to access port for chemotherapy infusion.Peripheral vein used, scarring and discomfort.Repeat surgery in hospital to install new port.Others in same facility same problem, ports replaced via surgery.Fda safety report id# (b)(4).

• Brand Name: POWER PORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BD / BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 11664062
• MDR Text Key: 245595457
• Report Number: MW5100768
• Device Sequence Number: 1
• Product Code: LJT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Weight: 127