MAUDE Adverse Event Report: Medical Components, Inc. VASCU-PICC®

Model Number	MD17012601
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	09/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Picc dressing noted to have drainage so primary rn asked for assistance changing dressing.Once old, soiled dressing was taken down, leaking noted to be coming from actual catheter and not from insertion site.Md notified and picc removed.Picc team attempted to get a new picc line but was unable to see a vein that she felt comfortable using.Piv placed instead.Brusing noted around the insertion site.Once picc removed, further inspection confirmed that there was a hole in actual catheter originating from the white lumen (lumen that had sedation and pressors infusing).
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: VASCU-PICC®
• Common Device Name: VASCU-PICC
• 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: 50884329
• Report Number: 2518902-2026-00068
• Device Sequence Number: 9939831
• Product Code: LJS
• UDI-Device Identifier: 00884908142167
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K102966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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: MD17012601
• Device Catalogue Number: MD17012601
• Device Lot Number: MSDH980
• 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: 09/21/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2026
• 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: Unknown