MAUDE Adverse Event Report: SMITHS MEDICAL MD, INC. DELTEC; PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 21-8466-24

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 01/04/2022

Event Type  malfunction  

Event Description

Port was placed in operating room (or).Interventional radiology (ir) did a port check after the clinic noticed leaking when injecting saline after accessing.During the dye study we noticed the port was leaking internally.When operating room removed the port the next day to replace with a new device, the radiologist checked to see where the leak was coming from.The back of the metal port is leaking.Medication was pooling in patient's chest.Port was removed and replaced in a second surgery for the patient.Removal and replacement surgery were successful.Product was removed from use.Hospital has retained the product and has reached out to the manufacturer for awareness.

Event Description

Port was placed in operating room (or).Interventional radiology (ir) did a port check after the clinic noticed leaking when injecting saline after accessing.During the dye study we noticed the port was leaking internally.When operating room removed the port the next day to replace with a new device, the radiologist checked to see where the leak was coming from.The back of the metal port is leaking.Medication was pooling in patient's chest.Port was removed and replaced in a second surgery for the patient.Removal and replacement surgery were successful.Product was removed from use.Hospital has retained the product and has reached out to the manufacturer for awareness.

Event Description

Port was placed in operating room (or).Interventional radiology (ir) did a port check after the clinic noticed leaking when injecting saline after accessing.During the dye study we noticed the port was leaking internally.When ir removed the port the next day to replace with a new device, the radiologist checked to see where the leak was coming from.The back of the metal port is leaking.Medication was pooling in patient's chest.Port was removed and replaced in a second surgery for the patient.Removal and replacement surgery were successful.Product was removed from use.Hospital has retained the product and has reached out to the manufacturer for awareness.

• Brand Name: DELTEC
• Type of Device: PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL MD, INC.; 6000 nathan ln n; minneapolis MN 55442
• MDR Report Key: 13577487
• MDR Text Key: 285941366
• Report Number: 13577487
• 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,Followup
• Report Date: 02/08/2022,02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 21-8466-24
• Device Catalogue Number: 21-8466-24
• Device Lot Number: 4073118
• 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: 02/08/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5840 DA
• Patient Sex: Male
• Patient Weight: 65 KG