MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. PRO-LINE®CT PRESSURE INJECTABLE CVC (ISOPLAST)

Model Number	MD28035201
Medical Device Problem Codes	Break (1069); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Possible broken broviac line a 5fr double lumen placed via the left internal jugular @ 27.5cm.Ct compatible line being replaced was 5fr dual lumen.P the white lumen was running heparin 200 units/ml in dextrose 5% in water + milrinone 600 mcg/ml in d5w and the purple/powerport lumen was running treprostinil 10,000 ng/ml in normal saline (never identified any other medication administration to this lumen) during this time frame.There were a few other iv medications administered during this time: o lorazepam iv x1 dose on 4/8 (2 mg/ml vial) o midazolam intravenous pro re nata dressing changes on 4/8, 4/10, and 4/17 (5 mg/ml 2 ml vial) o ondansetron iv on 4/7 and 4/9 (4 mg/2 ml vial).
Event or Problem Description
No device was returned and no photographs provided.Initial reporter stated issue was precipitate noted after infusing heparin and milrinone.Precipitate migrated to the device hub and was not able to be flushed or withdrawn.There was no issue with the device.
Additional Manufacturer Narrative
Initial reporter stated issue was precipitate noted after infusing heparin and milrinone.Precipitate migrated to the device hub and was not able to be flushed or withdrawn.There was no issue with the device.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a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: PRO-LINE®CT PRESSURE INJECTABLE CVC (ISOPLAST)
• Common Device Name: PRO-LINE®CT
• 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: 22097895
• Report Number: 2518902-2025-00027
• Device Sequence Number: 8354067
• Product Code: LJS
• UDI-Device Identifier: 00884908180497
• UDI-Public: (01)00884908180497(17)290128(10)MRPA120
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K093309
• 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): 06/20/2025

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 Model Number: MD28035201
• Device Catalogue Number: MD28035201
• Device Lot Number: MRPA120
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2024
• 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
• Patient Age: 9 YR
• Patient Sex: Female
• Patient Weight: 25 KG
• Patient Race: American Indian Or Alaskan Native