MAUDE Adverse Event Report: BD/ C. R. BARD, INC. BD POWERPORT DUO M.R.I. IMPLANTABLE PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Lot Number REEX1383

Device Problem Nonstandard Device (1420)

Patient Problem Insufficient Information (4580)

Event Date 03/29/2021

Event Type  Injury  

Event Description

This pt had a double lumen port placed on (b)(6) 2021, at (b)(6) medical center (b)(6).On or around (b)(6) 2021, (b)(6) received a recall notice from bd, the mfr.This was relate to the same port.On (b)(6) 2021, the pt's port was found to have malfunctioned as described in the recall.It was explanted on (b)(6) 2021.

• Brand Name: BD POWERPORT DUO M.R.I. IMPLANTABLE PORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BD/ C. R. BARD, INC.
• MDR Report Key: 11806217
• MDR Text Key: 250442614
• Report Number: MW5101279
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Lot Number: REEX1383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• 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): Required Intervention
• Patient Age: 27 YR
• Patient Weight: 64