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

Model Number	MRVSP26001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident was received from the fda.A voluntary report was received from a facility.The reporter requested to remain confidential.There is insufficient information in the report for an investigation, and no way to contact the reporter for additional information.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
Intravenous therapy to bedside to place new picc to replace current line with suspected break, once picc line successfully placed.Central intensive care unit's nurse practitioner discharged right arm picc and obvious large fracture identified.
Additional Manufacturer Narrative
The incident was received from the fda.They received a voluntary report from a facility.The reporter requested to remain confidential.There is insufficient information in the report for an investigation, and no way to contact the reporter for additional information.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 manufacture 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.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 (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 21157301
• Report Number: 2518902-2025-00003
• Device Sequence Number: 15583694
• Product Code: LJS
• UDI-Device Identifier: 00884908163391
• UDI-Public: 00884908163391
• Combination Product (Y/N): N
• PMA/510(K) Number: K120981
• 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): 01/23/2025

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 Expiration Date: 06/30/2026
• Device Model Number: MRVSP26001
• Device Catalogue Number: MRVSP26001
• Device Lot Number: MMLJ710
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2024
• 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: 8 DA
• Patient Sex: Male
• Patient Race: White