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

Model Number	MD17022601
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.Waiting for the device return 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.
Event or Problem Description
Patient's picc line found to have crack when line and hub met as medication found to be coming from picc line near insertion site underneath occlusive dressing.
Additional Manufacturer Narrative
The 2.6f picc was returned for evaluation with the end caps and a syringe still attached.As they are not related to the complaint, the end caps and syringe were discarded.Functional testing was performed by clamping the distal end of the lumen with hemostats and flushing the device through each of the luers.When flushed through the luer with the white clamp no leaks were noted.When flushed through the luer with the red clamp a leak was noted just below the picc hub.Under magnification it was noted that the lumen burst just below the hub.The area surrounding the burst is rippled, indicating the lumen ballooned prior to bursting.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was 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.The device was implanted for 15 days prior to the reported incident.We are unable to determine the cause or factors that may have contributed to this event.It appears that the device may have been flushed against resistance.The instructions for use (ifu) contains 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.

• Brand Name: 2.6F X 50CM DUAL PICC W/O OTN
• 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: 24257106
• Report Number: 2518902-2026-00008
• Device Sequence Number: 18540091
• Product Code: LJS
• UDI-Device Identifier: 00884908183184
• UDI-Public: (01)00884908183184(17)281111(10)MSBC230
• 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
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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: MD17022601
• Device Catalogue Number: MD17022601
• Device Lot Number: MSBC230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/16/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2025
• 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: 2 MO
• Patient Sex: Male
• Patient Weight: 4 KG