MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 4F SINGLE CT MIDLINE

Model Number	MLCT4S20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Device was implant on (b)(6) 2025.Patient suffers from several diseases and underwent ct scan.The images showed a tubular, hyperdense material in the pulmonary arterial branches, likely to be a catheter fragment.The device was found to be "trunked" and removed.Patient was kept under observation for seven days without any complications being observed.
Additional Manufacturer Narrative
We are currently waiting for the device to be returned for evaluation.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.
Additional Manufacturer Narrative
The device was not returned for evaluation and no photographs were provided.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured, assembled, and inspected according to specification with no non-conformances or abnormalities.Without an evaluation of the device the complaint cannot be confirmed, and a root cause cannot be determined.The instructions for use (ifu) contain the following warnings and potential complication: damage/fracture of catheter.The ifu also indicates the catheter should be examined for damage prior to insertion and before each use.The insertion and incident date are the same which indicates the damage to the catheter most likely occurred during the insertion procedure.The device should not be advanced or withdrawn forcibly from any component.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a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: 4F SINGLE CT MIDLINE
• Common Device Name: CT MIDLINE
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 22952324
• Report Number: 2518902-2025-00047
• Device Sequence Number: 9868263
• Product Code: PND
• UDI-Device Identifier: 00884908113730
• UDI-Public: (01)00884908113730(17)280213(10)MRRC980
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2025

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?: No
• Operator of Device: Other
• Device Model Number: MLCT4S20
• Device Catalogue Number: MLCT4S20
• Device Lot Number: MRRC980
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Sex: Unknown