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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Serious Injury
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 monitoring and management.On "[redacted]"-hospitalization day #45, the 2.6 fr picc line was found cracked at the hub when the picc rn came to assess and administered a tissue plasma activator (tpa), which is a thrombolytic agent, to the line.The tpa was administered to both lumens but after the dwell both lumens were still very sluggish with no blood return.The dressing was removed to further investigate and was found to be wet underneath.The line was then flushed with the dressing off and leaking was visible from catheter.On "[redacted]"-hospitalization day #47 a new picc was placed by iv rn on "[redacted]"-that day at 1123 at the bedside over a guidewire at the same site as the previous picc and midline.Picc breakage a result of user error, not device failure although there were still concerns regarding the product by the team.
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.

• 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: 50096989
• Report Number: 2518902-2026-00053
• Device Sequence Number: 13381664
• 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
• 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: 2 MO
• Patient Sex: Male
• Patient Race: White