MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 9.6F PRO-FUSE CT PORT

Model Number	MRCTT96801
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Our investigation is ongoing.A follow up report will be submitted when the investigation is complete.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 or Problem Description
The patient had a portacath inserted on the (b)(6) 2021 under sterile conditions in interventional radiology.It was accessed for treatment on the (b)(6) 2021 and a gripper needle was attached to do this.This was done as an aseptic technique.The iv medications were administered using antt.This was done as a day case in the (b)(6).She presented to ed on (b)(6) 2021 feeling unwell and with a temperature.Blood cultures were taken from the device which grew staphylococcal aureus.The device was removed on (b)(6) 2021 and this specimen also grew staph aureus in the laboratory sample.Further analysis is in progress.The patient's condition improved.
Additional Manufacturer Narrative
No device was returned for evaluation.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured according to specification with no non-conformances or abnormalities.Without an evaluation of the device a root cause cannot be determined.A review of the sterilization certificate indicated that the load this device was on 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.The product 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.

• Brand Name: 9.6F PRO-FUSE CT PORT
• Common Device Name: PRO-FUSE CT PORT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 12179897
• Report Number: 2518902-2021-00045
• Device Sequence Number: 1521465
• Product Code: LJT
• UDI-Device Identifier: 00884908031430
• UDI-Public: 884908031430
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 02/15/2022
• Device Model Number: MRCTT96801
• Device Catalogue Number: MRCTT96801
• Device Lot Number: MJMH570
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Weight: 101