MAUDE Adverse Event Report: NAVILYST MEDICAL, INC. SMART PORT CT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number CT66PTPDVI1

Device Problems Defective Device (2588); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 07/22/2021

Event Type  malfunction  

Event Description

Implant defective.The sleeve would not attach to port.Ref: ct66ptpdvi1.Lot: 5674817.Exp: 02/29/2024.

• Brand Name: SMART PORT CT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): NAVILYST MEDICAL, INC.; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 12384046
• MDR Text Key: 268718719
• Report Number: 12384046
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CT66PTPDVI1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Weight: 74