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

Catalog Number 1808560

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 06/13/2023

Event Type  Injury  

Event Description

Power port, originally inserted in (b)(6) 2020, had several problems over three years including pain with injection.Patient had "port study" completed showing "leaking" at the distal end of catheter.Port removed (b)(6) 2023.Upon inspection of removed port several cracks were seen at distal end of catheter.

• Brand Name: POWER PORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 17143543
• MDR Text Key: 317477007
• Report Number: MW5118432
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/13/2023

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: 11/30/2022
• Device Catalogue Number: 1808560
• Device Lot Number: REDV1507
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White