MAUDE Adverse Event Report: ST PAUL PORT A CATH; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRA

Device Problems Obstruction of Flow (2423); Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 11/22/2022

Event Type  malfunction  

Manufacturer Narrative

Model#: catalog and lot numbers, udi section are unknown, information provided cannot be verified.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.

Event Description

It was reported that the patient was scheduled for a vesicant chemo administration but was found to have no blood returning from the port.Tpa installed twice with continued inability to aspirate blood.A cxr was performed to evaluate placement.The left chest wall tubing was found disconnected with significant migration of the tubing.Chemotherapy was not given and the patient was scheduled for a port removal and replacement.The port was placed 15 december 2021 and replaced on 28 november 2022.Customer has provided the following product information, however it cannot be verified at this time: reported lot #:5693825, reported serial #:(b)(4), and reported expiration date: 08/31/24.There has been no report of observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

It has been determined that complaint file (b)(6) with a manufacturing report number of 3012307300-2023-00723 is a duplicate complaint entered in error.Please disregard the previous submission(s).Any additional reporting will be conducted under the applicable file.

• Brand Name: PORT A CATH
• Type of Device: PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRA
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16264886
• MDR Text Key: 308383385
• Report Number: 3012307300-2023-00723
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR