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

Model Number	MD17012601
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.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.
Event or Problem Description
The patient's picc line was not drawing back.The patient's leg had a hard swollen spot.The line was removed due to concern of infiltration.When the line was pulled, there was a fracture in the line that looked to be about where the swelling was on the patient's let.Infiltration was moderate.No additional interventions were required.No harm to the patient was noted.
Additional Manufacturer Narrative
The 2.6f picc was returned for evaluation.Visual inspection revealed a burst in the lumen approximately 9.5 cm distal to the hub, continuing approximately 0.5 cm down the lumen.A second lumen burst can be seen approximately 0.5 cm distal to the first burst.A significant blood clot was expressed from the second hole when flushing.The condition of the returned device suggests flushing against resistance may have caused the lumen to burst.The device was further evaluated by medcomp engineering.The location of the holes shows obvious signs of the lumen ballooning, which weakens the structure and, in turn, resulted in the lumen bursting.Flushing against a kink in the line or an occlusion may have resulted in the complaint condition.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.A root cause cannot be determined but is not likely manufacture related.Excessive external pressure applied to the lumen may be a contributing cause for this type of failure.The instructions for use (ifu) include warnings and parameters for infusion equipment and bolus injections to avoid excessive pressures.If resistance is encountered to aspirating or flushing, the lumen may be partially or completely occluded.Do not flush against resistance.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: 21927207
• Report Number: 2518902-2025-00020
• Device Sequence Number: 18397511
• Product Code: LJS
• UDI-Device Identifier: 00884908146493
• UDI-Public: (01)00884908146493(17)270801(10)MRRS420
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: MD17012601
• Device Catalogue Number: MD17012601
• Device Lot Number: MRRS420
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown