MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. TRAY INFUSION PORT PORTACATH; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 21-4455-24

Device Problems Difficult to Flush (1251); Fracture (1260); Obstruction of Flow (2423)

Patient Problem Failure of Implant (1924)

Event Date 07/14/2022

Event Type  Injury  

Event Description

Patient was taken to the operating room for replacement of the device secondary to the device clotting off, would not flush with extravasation of fluid around the reservoir.The patient had received neoadjuvant therapy since placement of the catheter which occurred on (b)(6) 2022.Upon removal of the catheter, it was noted to have a fracture in the midportion of the catheter which would have been present from manufacture date.Fda safety report id# (b)(4).

• Brand Name: TRAY INFUSION PORT PORTACATH
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 15078610
• MDR Text Key: 296410722
• Report Number: MW5111031
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• 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: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-4455-24
• Device Lot Number: 4196752
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 31 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White