MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 3FX60CM SGL VASCU-LINE W/CUFF

Model Number	MR28013121
Medical Device Problem Codes	Fracture (1260); Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
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
Fractured central line - 3 french cuffed picc.Location of fracture: connection where clear portion meets white portion just before cap connection.Location of line: right basilic.Parents performed the 4 "c" clamp between fracture and insertion site, clean with chlorhexidine and cover with sterile occlusive dressing.Required a rewire under general anesthesia.
Additional Manufacturer Narrative
The device was not returned and no photographs were provided.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 specifications with no non-conformances or abnormalities.The process includes a leak test at 45 psi after the molding process and a 100% leak test at the very end of the manufacture process.These tests would have detected a hole or weak spot if it had existed at the time of manufacture.Without photographs or an evaluation of the device the complaint cannot be confirmed and a root cause cannot be determined.The instructions for use (ifu) contains the following precautions: do not use sharp instruments near the extension lines or catheter lumen.Do not use scissors to remove dressing.Catheter will be damaged if clamps other than what is provided with this kit are used.Clamping of the tubing repeatedly in the same location will weaken tubing.Avoid clamping near the luer(s) and hub of the catheter.Based on historic data this is not a systemic issue and is considered an isolated incident.This type of event will be trended through the complaint handling process.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: 3FX60CM SGL VASCU-LINE W/CUFF
• Common Device Name: VASCU-LINE
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 12224573
• Report Number: 2518902-2021-00049
• Device Sequence Number: 4255512
• Product Code: LJS
• UDI-Device Identifier: 00884908094855
• UDI-Public: 884908094855
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 11/14/2022
• Device Model Number: MR28013121
• Device Catalogue Number: MR28013121
• Device Lot Number: MNSX630
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 07/26/2021
• Supplement Report FDA Received Date: 08/30/2021
• 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