MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. VASCU-PICC®

Model Number	MR17012601
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Picc became blocked-tried flushing line x 3.Finally able to flush and line appeared cracked as dressing filled up with fluid/blood.Picc currently still in patient.
Additional 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.
Additional Manufacturer Narrative
The device was not returned for evaluation.Multiple attempts to obtain the device were unsuccessful.The manufacturing process for this device includes a 100% leak test performed as a last step in the process.This test would have detected any leaks, holes, or weak spots if it had existed at the time of manufacture.The device was implanted 6 days prior to the issue.Without sufficient information, or an evaluation of the device involved, we are unable to determine the root cause or factors that may have contributed to this event.The report indicated that the catheter was blocked, and the leak occurred after flushing x3 to clear the blockage.Excessive external pressure applied to the lumen may be a contributing cause for this type of failure.The instructions for use (ifu) include warnings and parameters for infusion equipment and bolus injections to avoid excessive pressures.If resistance is encountered to aspirating or flushing, the lumen may be partially or completely occluded.Do not flush against resistance.

• Brand Name: VASCU-PICC®
• Common Device Name: VASCU-PICC
• 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: 21584559
• Report Number: 2518902-2025-00015
• Device Sequence Number: 9467440
• Product Code: LJS
• UDI-Device Identifier: 00884908085693
• UDI-Public: 00884908085693
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

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 Expiration Date: 02/01/2026
• Device Model Number: MR17012601
• Device Catalogue Number: MR17012601
• Device Lot Number: MQXW510
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2023
• 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