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)
Date of Event	10/30/2025
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
Issue identified with white lumen of lue(left upper extremity) 2.6fr picc was flushed with 10mls of nss as per policy.Rn clamped the line and paged iv team.During the day rue(right upper extremity) us obtained that was unremarkable.Cardiac intensive care unit and peripheral nervous system changed the dressing to ensure there was no mechanical obstruction.Red lumen flushed at this time and flushed and withdrew blood without issue.When patient's white lumen was flushed the nss immediately filled the dressing window and biopatch.Cardiology app called to bedside and line was removed at this time.A visible tear in the catheter was present after removal and found to be 1.5cm past the hub of the catheter.
Additional Manufacturer Narrative
No devices were returned for evaluation, and no photographs were provided.The contract manufacturer conducted a review of the manufacturing records for the lot number reported.Their investigation revealed the devices were manufactured and inspected according to specification with no non-conformances or abnormalities.The manufacturing process 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.Without an evaluation of the device the complaint cannot be confirmed, and a root cause cannot be determined.The instructions for use (ifu) contain the following warnings and precautions.*do not use infusion equipment which can exceed the working pressure of 1.0bar max/750mmhg (14.5 psi).*only use infusion equipment complying with standards, which do not exceed a shut-off pressure of 1.0bar.*bolus injections should be slow and must not exceed the maximum bolus pressure of 1.2bar/900mmhg (17.4 psi).*small syringes will generate excessive pressure and may damage the catheter.The use of 10cc or larger syringes are recommended.*do not flush against resistance.*if the lumen will neither aspirate nor flush, and it has been determined that the catheter is occluded with blood, follow institutional declotting procedure.*do not use sharp instruments near the extension lines or catheter lumen 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 ; 2152564201
• MDR Report Key: 23681188
• Report Number: 2518902-2025-00069
• Device Sequence Number: 9846444
• Product Code: LJS
• UDI-Device Identifier: 00884908180183
• UDI-Public: (01)00884908180183(17)280716(10)MRXB830
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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: MRXB830
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2025
• 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: 24 MO
• Patient Sex: Female