MAUDE Adverse Event Report: BARD DUO MEDIPORT; "CATHETER INTRAVASCULAR"

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/02/2017

Event Type  Injury  

Event Description

Pt had removal of duo mediport due to no longer needed.A f/u radiograph identified a small thin metalic plate associated with the mediport within the soft tissues.

• Brand Name: DUO MEDIPORT
• Type of Device: "CATHETER INTRAVASCULAR"
• Manufacturer (Section D): BARD; bryan OH 43506
• MDR Report Key: 6636320
• MDR Text Key: 77531314
• Report Number: MW5070356
• 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: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• 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): Other
• Patient Age: 69 YR