MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 6.6F DIG MS CT W/ATTACH PU; DIGNITY CT PORT

Model Number MRCTI66001-KR

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2023

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 available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

After insertion of the port, a leak was noted during injection of saline solution.

Manufacturer Narrative

The 6.6f dignity port was returned for evaluation with approximately 20 cm of lumen attached to the port stem with a locking collar.The distal end of the lumen was clamped, and a huber needle was used to inject fluid into the port.No leaks were noted from the port, stem connection, or the lumen.No problem was found with the returned device.A video was provided showing what appears to be leakage around the edge of the port.However, the video quality is not sufficient to determine where the leak originates.We cannot determine the circumstances that may have contributed to the reported event as the returned device functioned as intended.No further investigation is necessary.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: 6.6F DIG MS CT W/ATTACH PU
• Type of Device: DIGNITY CT PORT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 18268819
• MDR Text Key: 329806425
• Report Number: 2518902-2023-00072
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2023

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
• Device Operator: Other
• Device Model Number: MRCTI66001-KR
• Device Catalogue Number: MRCTI66001-KR
• Device Lot Number: MQWH770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 11/17/2023
• Supplement Dates FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention