MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 4F SINGLE CT MIDLINE

Model Number	MLCT4S20
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device sample is entering the investigation process.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 avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Line fractured while in use, medication leaking from crack in line.
Additional Manufacturer Narrative
The 4f midline was returned for evaluation.Visual inspection confirmed the complaint.There is a cut in the extension line approximately 5.5 cm from the luer.The cut encircles more than ¾ the diameter of the extension line.There is an excessive amount of adhesive on the device in the area of the cut, suspected to be from the implant site dressing.When viewed under magnification, the cut appears smooth through most of the opening and only slightly jagged for a small portion of the cut.It is possible the cut was made with a sharp instrument such as scissors.Once the cut was made, the material continued to tear, causing the slightly jagged appearance to part of the tear.The device was implanted for 10 days prior to the failure.This indicates the lumen cut was not present when the device was inserted.There is no evidence of a manufacturing error.Root cause of the issue is determined to be a cut by a sharp instrument such as scissors.The instructions for use (ifu) contains the following catheter precautions: always use caution when using sharp instruments near the extension lines or catheter lumen.Do not use scissors to remove dressing.Device was used for treatment, not diagnosis.If information is obtained that was not avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4F SINGLE CT MIDLINE
• Common Device Name: CT MIDLINE
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 10308262
• Report Number: 2518902-2020-00032
• Device Sequence Number: 16344559
• Product Code: PND
• UDI-Device Identifier: 00884908113730
• UDI-Public: 884908113730
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2020

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: 01/06/2023
• Device Model Number: MLCT4S20
• Device Catalogue Number: MLCT4S20
• Device Lot Number: MNVR570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 08/13/2020
• 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