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

Model Number	MD170126024S
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Baby had a left hemithorax, tested the pleural fluid and it has triglycerides and glucose consistent with a l hemithorax.Chest tube was placed after clinical decompensation.Team suspected potential infiltration of tpn/lipids from picc.Picc was d/c'd and tpn was stopped and chest tube output immediately stopped.Clinical decompensation, has now improved and was extubated.
Additional Manufacturer Narrative
Our investigation is ongoing.A follow up report will be submitted when the investigation is complete.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.
Additional Manufacturer Narrative
The 2.6f vascu picc was returned for evaluation with approximately 6.5 cm of lumen attached.Visual inspection revealed no obvious defects.Functional testing was performed by clamping distal end of lumen and flushing through both luers.No leaks were noted.The device was then aspirated through both luers and functioned as designed.No issue was found with the returned device.No direct connection between the incident description and the picc can be determined.No device failure was found.The instruction for use includes the potential complication of perforation of the vessel.Also included in the ifu is "confirm catheter tip position by x-ray prior to use.Monitor tip placement routinely per institution policy.".

• 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: 20787811
• Report Number: 2518902-2024-00078
• Device Sequence Number: 15201117
• Product Code: LJS
• UDI-Device Identifier: 00884908147230
• UDI-Public: 00884908147230
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K120981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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: 04/30/2026
• Device Model Number: MD170126024S
• Device Catalogue Number: MD170126024S
• Device Lot Number: MRBY720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2024
• 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: 11/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• 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 Sex: Male