MAUDE Adverse Event Report: Medical Components, Inc. 2.6F X 50CM DUAL VASCU-PICC TLS; Vascu-PICC®

Model Number	MRVSP26001
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Extravasation (1842); Infiltration into Tissue (1931)
Date of Event	09/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Picc lime was noted to be leaking and had drainage at insertion site.Dressing change was done and line was flushed.Drainage and leakage was again noted.Line attempted to be removed and resistance was noted.Physician came to remove line.It was flushed and catheter noted to be broken.Patient experienced mild peripheral intravenous infiltration and extravasation (pivie).
Additional Manufacturer Narrative
An investigation has been initiated.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 VASCU-PICC TLS
• Common Device Name: Vascu-PICC®
• Manufacturer (Section D): Medical Components, Inc.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: susan smith ; 1499 delp drive; harleysville, PA 19438 ; +1(215)256-4201
• MDR Report Key: 50778030
• Report Number: 2518902-2026-00066
• Device Sequence Number: 9826819
• Product Code: LJS
• UDI-Device Identifier: 00884908163391
• UDI-Public: (01)00884908163391(17)280101(10)MMMG960
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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: MRVSP26001
• Device Catalogue Number: MRVSP26001
• Device Lot Number: MMMG960
• 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: 09/09/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2026
• 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 Sex: Unknown