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

Lot Number REAU1511

Device Problem Fracture (1260)

Patient Problem Numbness (2415)

Event Date 06/06/2017

Event Type  malfunction  

Event Description

The patient had chemotherapy end of (b)(6).Presents to same day care the next day complaining of numbness around anterior chest wall-port site.Patient assessed for possible cellulitis.Requested port removal and upon removal of port and examination found port to have a fracture identified within catheter material approximately 5 cm from its junction with the power port.

• Brand Name: POWERPORT
• 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: 6683883
• MDR Text Key: 78955517
• Report Number: 6683883
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/09/2017

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: Nurse
• Device Lot Number: REAU1511
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/09/2017
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CHEMOTHERAPY; NO
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 91