MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. TRAY INFUSION PORT PORTACATH - LOG8168329; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Lot Number 4248703

Device Problems Crack (1135); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/14/2022

Event Type  Injury  

Event Description

Device was placed on (b)(6) 2022.On (b)(6) 2022, the patient reported pain at the site after undergoing chemotherapy.A pac study was done which identified a fracture in the device below the clavicle.During device removal on (b)(6) 2022, the pac reservoir was removed and preserved for return to the manufacturer.A fracture was noted at the hub of the reservoir where the catheter was anchored to the device.The remaining catheter had retracted into the vein, inferior to the clavicle and the surgeon was not able to retrieve the catheter.The patient was referred to interventional radiology for removal.

• Brand Name: TRAY INFUSION PORT PORTACATH - LOG8168329
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.
• MDR Report Key: 16086076
• MDR Text Key: 306655468
• Report Number: MW5114121
• 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: 12/15/2022

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 Lot Number: 4248703
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American