MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 9.5F DIGNITY DUEL LUMEN CT PORT

Model Number	MRDP95ADS
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
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
Patient presented to have cadd (computer-aided drug discovery) pump changed.Difficult blood return noted.Superior port site leaking.Port was flushed, de-accessed.Accessed inferior lumen and connected pump.Additional information provided by risk manager: "during visit, the superior port site was slightly reddened.She was instructed to go to the ed if it got worse.The following day, she went to ed with increased reddening and given a course of antibiotics for possible port site infection.Patient continues to received her treatments using the lateral port.".
Additional Manufacturer Narrative
The device was unavailable for evaluation as it remains implanted in the patient.The contract manufacturer of the port and lumen conducted a review of the manufacture records for the lot numbers reported.Their investigation showed the devices were manufactured according to specification with no non-conformances or abnormalities.The last step in the manufacture process includes a 100% leak test.This test would have revealed a leak or weakness if it had existed at the time of manufacture.Without an evaluation of the device involved we are unable to determine the cause or factors that may have contributed to this event.Possible complications listed in the instructions for use include: catheter or port related sepsis, extravasation, catheter occlusion.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: 9.5F DIGNITY DUEL LUMEN CT PORT
• Common Device Name: DIGNITY DUEL LUMEN CT PORT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 12023805
• Report Number: 2518902-2021-00030
• Device Sequence Number: 4204988
• Product Code: LJT
• UDI-Device Identifier: 00884908115567
• UDI-Public: 884908115567
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K153238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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: 08/31/2025
• Device Model Number: MRDP95ADS
• Device Catalogue Number: MRDP95ADS
• Device Lot Number: MPMK180 S2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/21/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 06/25/2021
• 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: 73 YR
• Patient Weight: 62