MAUDE Adverse Event Report: Medical Components, Inc. CT Midline Catheter

Model Number	MLCT4S20
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During midline insertion guidewire lodged in the subcutaneous tissue.During the difficult removal process, a knot was observed in the guidewire.
Additional Manufacturer Narrative
We are currently waiting for the device to be returned for evaluation.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.

• Brand Name: CT Midline Catheter
• 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 ; +1(215)256-4201
• MDR Report Key: 50172846
• Report Number: 2518902-2026-00055
• Device Sequence Number: 9860680
• Product Code: PND
• UDI-Device Identifier: 00884908113730
• UDI-Public: (01)00884908113730(17)290522(10)MSHJ770
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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: Health Professional
• Device Model Number: MLCT4S20
• Device Catalogue Number: MLCT4S20
• Device Lot Number: MSHJ770
• 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: 08/07/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2026
• 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: 81 YR
• Patient Sex: Unknown