MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 6.6F DIGNITY LP CT PORT; DIGNITY CT-PORT

Model Number MRDP66PLS

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/30/2021

Event Type  Injury  

Manufacturer Narrative

A review of the sterilization certificates for the loads the lots were processed on indicated that the loads passed all requirements of sterilization.There were no non-conformances during the sterilization process.Sterilization of medcomp product is performed according to iso standard 11135 "medical devices- validation and routine control of ethylene oxide sterilization".Infections are the most common complication after implantation of a venous port system.Infections of port venous systems include pocket and/or tunnel cellulitis or the more common catheter-related blood stream infections.Instructions for use contain the following potential complication- catheter or port related sepsis.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The facility submitted a voluntary event report stating there were three bloodstream infections in oncology patients with port over 18 day period.No other information was provided.

• Brand Name: 6.6F DIGNITY LP CT PORT
• Type of Device: DIGNITY CT-PORT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 11723627
• MDR Text Key: 247229256
• Report Number: 2518902-2021-00023
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00884908149890
• UDI-Public: 884908149890
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MRDP66PLS
• Device Catalogue Number: MRDP66PLS
• Device Lot Number: MNXJ480, MPFN020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1