MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 5F DIGNITY LOW PROFILE CT PORT; DIGNITY CT-PORT

Model Number	MRDP50PLS
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Previous port-a-catheter was malfunctioning.A crack was noted upon explantation.
Additional Manufacturer Narrative
Multiple requests for clarification and additional information were not successful.Without knowing what the reported malfunction is or if it occurred on the port or lumen, no further investigation is possible.If the requested information and clarification should become available the complaint will be reopened and investigated further.Device was used for treatment, not diagnosis.If information is obtained that was not avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5F DIGNITY LOW PROFILE CT PORT
• Common Device Name: DIGNITY CT-PORT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 10415096
• Report Number: 2518902-2020-00041
• Device Sequence Number: 14123786
• Product Code: LJT
• UDI-Device Identifier: 00884908149777
• UDI-Public: 884908149777
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K132177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2020

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: 04/30/2022
• Device Model Number: MRDP50PLS
• Device Catalogue Number: MRDP50PLS
• Device Lot Number: MLAZ860 S2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 09/10/2020
• 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: 3 YR