MAUDE Adverse Event Report: Medical Components, Inc. 2.6F X 20CM DUAL VASCU-PICC; Vascu-PICC®

Model Number	MR170126224S
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Device leaking.
Additional Manufacturer Narrative
An investigation has been initiated.Currently waiting for additional information and the device to be returned for evaluation if available.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: 2.6F X 20CM DUAL VASCU-PICC
• Common Device Name: Vascu-PICC®
• Manufacturer (Section D): Medical Components, Inc.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: susan smith ; 1499 delp drive; harleysville, PA 19438 ; +1(215)256-4201
• MDR Report Key: 50883029
• Report Number: 2518902-2026-00069
• Device Sequence Number: 15937498
• Product Code: LJS
• UDI-Device Identifier: 00884908105148
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: MR170126224S
• Device Catalogue Number: MR170126224S
• Device Lot Number: MSJN010
• Was Device Available for Evaluation?: No
• 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: 09/23/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2026
• 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 Sex: Male
• Patient Weight: 6 LB