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

Model Number	MD17012601
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated.Currently waiting for additional information.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.
Event or Problem Description
This event involves a patient who was admitted to "[redacted]" pediatric intensive care unit (picu) on "[redacted]" from an outside hospital for surgical management.On "[redacted]"-the day of admission, the patient underwent surgery for an open external incision and drainage of the retropharyngeal and mediastinal abscess via the left neck.On "[redacted]"-post-op day 1, the patient underwent a bedside procedure to insert a peripherally inserted central catheter (picc) in the right upper extremity for antibiotic therapy without complication.On "[redacted]"-post-op day 7, the patient demonstrated wincing when the white port of the picc line was flushed as per routine.Initially a 10 cubic centimeter (cc) syringe was used to flush the port but was met with resistance.A second attempt was made to flush the port with a 3cc syringe that was filled with heparin prior to flushing.The patient continued to wince, and leaking was noted at the insertion site.An intravenous team (iv) nurse was consulted to evaluate the site.Assessment of the picc also indicated that the red port was not flushing.A decision was made to discontinue use of the line and to remove the picc.On "[redacted]"-post-op day 8, after removal of the picc, a small fracture was noted in the line at the 2.75-centimeter (cm) mark.On "[redacted]"-post-op day 9, the patient was scheduled for a chest tube insertion in the operating room (or) and in order to minimize the need for additional anesthesia, the patient also underwent replacement of the picc by the iv team in the left upper extremity while in the operating room.

• Brand Name: VASCU-PICC®
• Common Device Name: VASCU-PICC Infusion catheter
• 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: 50096990
• Report Number: 2518902-2026-00052
• Device Sequence Number: 10479112
• Product Code: LJS
• UDI-Device Identifier: 00884908142167
• UDI-Public: (01)00884908142167
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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: Other
• Device Model Number: MD17012601
• Device Catalogue Number: MD17012601
• 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: 07/30/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 10 MO
• Patient Sex: Male
• Patient Race: White