MAUDE Adverse Event Report: BARD ACCESS SYSTEM POWER PORT IMPLANTABLE PORT; PICC

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2014

Event Type  Other  

Event Description

His wife had surgery because she had breast cancer that has metastasized to the bone.The device is planted in her left breast.She was getting chemotherapy and the device worked 3 days after the surgery.That is the only time it worked.When trying to operate it, blood wouldn't come out.When they communicated the problem to dr.(b)(6) , her healthcare professional, he flushed it and told them that it should work.However, the device did not work.Her chemotherapy team flushed it as well, but it did not make a difference.So far it has been flushed 15 times or so, but it is still not working.

• Brand Name: POWER PORT IMPLANTABLE PORT
• Type of Device: PICC
• Manufacturer (Section D): BARD ACCESS SYSTEM
• MDR Report Key: 4524352
• MDR Text Key: 5491959
• Report Number: MW5040757
• Device Sequence Number: 1
• Product Code: LJT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Other Device ID Number: 1808002
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 89