MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. POWERPORT ISP IMPLANTABLE PORT; MEDIPORT

Lot Number REBP1621

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Palpitations (2467)

Event Date 05/15/2017

Event Type  Injury  

Event Description

Presented to (b)(6) hospital emergency department with complaint of palpitations.Notified by providers at (b)(6) that remote cardiac monitoring showed possible new onset of atrial fibrillation and recommended him to present to er for evaluation.Chest x-ray revealed mediport catheter dislodged.Required further treatment at (b)(6) with removal of port and separated portion of the port.A new port was inserted.

• Brand Name: POWERPORT ISP IMPLANTABLE PORT
• Type of Device: MEDIPORT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ 85281
• MDR Report Key: 6647118
• MDR Text Key: 77846221
• Report Number: MW5070459
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Lot Number: REBP1621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 195