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

Model Number	MD170126024S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 2.6f picc was returned for evaluation.Visual inspection confirmed the complaint as a rupture can be seen approximately 1 cm distal to the hub.Under magnification it can be seen that the lumen material is "rippled" around the rupture area.This condition is indicative of flushing against resistance or infusing at a higher pressure than the device is designed to withstand, causing the lumen material to stretch and balloon prior to rupturing.Without the lot number a review of the manufacture records is not possible.The device was implanted and functioned with no reported issues for more than 2 months.A definitive root cause cannot be determined but is not likely manufacture related.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.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
Patient had 2.6 fr, double lumen, medcomp picc that was placed (b)(6) 2025, that was found on (b)(6) 2025 to be out of the insertion site by approximately 2 cm.Upon visualization of the picc through the dressing window, small area of outpouching noted approximately 0.75 cm from hub.Red lumen was still infusing heparin solution for monitoring of cvp.White lumen was flushed per policy, and significant leaking was visualized at the area of outpouching that was previously mentioned.
Additional Manufacturer Narrative
We are currently waiting for the device to be returned for evaluation.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: 23415495
• Report Number: 2518902-2025-00062
• Device Sequence Number: 21069177
• Product Code: LJS
• UDI-Device Identifier: 00884908183139
• UDI-Public: 00884908183139
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K120981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

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: MD170126024S
• Device Catalogue Number: MD170126024S
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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