MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 6.6F MINI DIGNITY CT PORT

Model Number	MIDP66AXS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The dignity mini port was returned for evaluation and forwarded to medcomp engineering for review.Visual examination showed the port is broken into two pieces.It was noted that a small fragment along the break line is missing.A definitive root cause could not be determined.The port was implanted for 10 months and no infiltration problems were noted.In addition, the subcutaneous pocket showed no signs of tissue damage as a result of an infiltration.The port may have been damaged during the removal procedure.
Event or Problem Description
Patient was having port removed.Upon removal the doctor had noticed that the plastic port casing had cracked and broken in to two pieces.The doctor noted that the pocket was clean and healthy, no damage to the patient or evidence of any medication leaking from the port.

• Brand Name: 6.6F MINI DIGNITY CT PORT
• Common Device Name: DIGNITY CT PORT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 9432218
• Report Number: 2518902-2019-00076
• Device Sequence Number: 1711139
• Product Code: LJT
• UDI-Device Identifier: 00884908149470
• UDI-Public: 884908149470
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: MIDP66AXS
• Device Catalogue Number: MIDP66AXS
• Device Lot Number: MNCB190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR