MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 2.6F X 50CM DUAL VASCU-PICC; VASCU-PICC®

Model Number	MD17012601
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 2.6f vascu picc was returned for evaluation.Visual inspection revealed no obvious defects.Functional testing was performed by clamping the distal end of the lumen with hemostats.When flushed through the luer with the red clamp no leaks were noted.When flushed through the luer with the white clamp a leak was noted in the lumen approximately 0.5 cm distal to the hub.Under magnification it was noted that the leak is from a small rupture in the lumen running lengthwise.The edges of the rupture appear wavy and rippled, suggesting the lumen bulged prior to bursting, possibly due to flushing against resistance.No lot number was provided.Without a lot number a review of the manufacturing records is not possible.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.A root cause cannot be determined but is most likely not manufacturing related.The instructions for use (ifu) contain the following warnings: 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.
Additional Manufacturer Narrative
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
At 1600 rn returns patient to bed from moms' arms after drawing blood from picc line and csf from evd.Mom notices a wet spot on her shirt leading to the discovery of a newly infiltrated lue picc.This line was placed (b)(6).Faulty line removed from pt.New picc placed by picc team successfully and confirmed by xray.

• Brand Name: 2.6F X 50CM DUAL 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: 24187815
• Report Number: 2518902-2026-00007
• Device Sequence Number: 8065035
• Product Code: LJS
• UDI-Device Identifier: 00884908142167
• UDI-Public: (01)00884908142167
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2026
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 02/13/2026
• 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): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female