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

Model Number MRDP50PLS

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 Description

Previous port-a-catheter was malfunctioning.A crack was noted upon explantation.

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
• Type of Device: DIGNITY CT-PORT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 10415096
• MDR Text Key: 204049885
• Report Number: 2518902-2020-00041
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00884908149777
• UDI-Public: 884908149777
• Combination Product (y/n): N
• PMA/PMN Number: K132177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR