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

Model Number	MD17012600
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The nurse was placing a picc [peripherally inserted central catheter] line in patient as ordered.The patient was prepped and a 3 french 5cm introducer/dilator was inserted without issue.A 2.6 french double lumen picc was then opened and advanced through the introducer without resistance.While flushing the picc to check for patency, the red lumen was noted to be leaking at the insertion site.The white lumen remained intact.A defect of the picc line was identified and the line was removed and replaced with another 2.6 french double lumen picc of the same lot number.No leaking was noted in either lumen of the second picc line placed.

• 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 ; 2152564201
• MDR Report Key: 25278941
• Report Number: 2518902-2026-00036
• Device Sequence Number: 10085937
• Product Code: LJS
• UDI-Device Identifier: 00884908180183
• UDI-Public: (01)00884908180183(17)290109(10)MSCK990
• Combination Product (Y/N): N
• PMA/510(K) Number: K102966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2026

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: MD17012600
• Device Catalogue Number: MD17012600
• Device Lot Number: MSCK990
• 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: 05/26/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2026
• 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 Age: 7 DA
• Patient Sex: Male
• Patient Weight: 3 KG
• Patient Ethnicity: Hispanic
• Patient Race: White