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

Lot Number REDN2391

Device Problems Unintended Movement (3026); Separation Problem (4043)

Patient Problem Insufficient Information (4580)

Event Date 09/26/2020

Event Type  malfunction  

Event Description

The toddler patient was receiving weekly infusion at home for hemophilia via his implanted port since july last year.Last month, the family brought the patient to (b)(6) hospital outpatient satellite infusion center due to problems with the implanted port at home.There was a chest x-ray obtained upon their arrival which determined that the catheter piece of the implanted port had separated from the subcutaneous septum and drifted into the pulmonary artery.The patient was emergency transported by ambulance to the (b)(6) hospital main campus emergency room.He was admitted and had a cardiology consult.He had a procedure in the cardiac cath lab for successful retrieval of the implanted port catheter from the vessel.The implanted port pieces were removed, and a new implanted port was placed.Manufacturer response for implantable port single lumen, bard implantable port (per site reporter): company representative asked for us to return product them for analysis.

• Brand Name: POWERPORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 12452376
• MDR Text Key: 270875111
• Report Number: 12452376
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: REDN2391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/03/2021
• Device Age: 1 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 730 DA
• Patient Weight: 15