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

Model Number	MR170126024S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
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
The physician inserted the picc into a patient.After which leakage was observed.In an attempt to replace it, they introduced a guidewire into the leaking picc and tried to insert a new line over the wire.It's unclear whether the defect (a hole in the picc) was present initially and caused the leak or whether it occurred during the guidewire insertion.
Additional Manufacturer Narrative
The 2.6f picc was returned for evaluation.Functional testing revealed a leak in the lumen just below the hub when the device is flushed through both luers.Under magnification it was noted that the lumen appears to have been cut with a sharp instrument such as scissors or a scalpel.The issue was discussed with medcomp engineering.An investigation request was issued to the device contract manufacturer for this event.The investigation revealed the damaged area identified on the returned unit consists of a perforation in the lumen below the hub.Replication testing demonstrated that a similar perforation, when intentionally introduced, is readily detected and rejected during the 100% leak test performed as a last step in the manufacturing process.Therefore, such damage would not pass final inspection controls.It is determined the reported failure is not related to the manufacturing process.We are unable to determine a definitive root cause for the failure however it may have occurred during the insertion procedure.The instructions for use (ifu) contain the following warnings and precautions.Do not use sharp instruments near the extension lines or catheter lumen.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 LUMEN PICC W/MST
• 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: 23742720
• Report Number: 2518902-2025-00072
• Device Sequence Number: 8420815
• Product Code: LJS
• UDI-Device Identifier: 00884908105131
• UDI-Public: (01)00884908105131(17)270228(10)MRNL580
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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: MR170126024S
• Device Catalogue Number: MR170126024S
• Device Lot Number: MRNL580
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 4 MO
• Patient Sex: Male