MAUDE Adverse Event Report: LINEUS MEDICAL SAFEBREAK VASCULAR

Catalog Number	2855-01-0001
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Hyperglycemia (1905); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Problem: leaks from the end of the safebreak device & the iv tubing event: (specific date not provided).A nurse reported that while managing a patient requiring an insulin infusion (insulin gtt) via glucommander, a leaking intravenous (iv) connection was observed.Upon entering the patient's room to cosign a new bag of insulin, she noticed the patient had a pillow under their arm, which was soaked.The insulin infusion was running through an iv in the same arm.The attending nurse reported ongoing leakage from the iv setup, which included a safebreak device.Upon assessing the iv, she confirmed that the leakage originated from the end of the safebreak.As a result of this leakage, the glucommander system detected rising blood glucose levels and automatically increased the insulin infusion rate to compensate, eventually reaching a high dose.After disconnecting the safebreak, the insulin infusion rate decreased, and the patient's glucose levels stabilized.
Additional Manufacturer Narrative
The device was not returned.Dhr review confirmed no manufacturing deviations and review of coc confirmed female luer was within specification.Analysis of the complainant device could not be completed.Unable to determine if leak was the result of the device itself or improper connection of the device with the administration tubing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
Patient required an insulin gtt using glucommander.His nurse asked another nurse to co-sign a new bag of insulin.Upon entering the room, the co-signing nurse inspected the insulin gtt iv and noted that the pillow under that same arm was wet.The primary nurse told the co-signing nurse that she was having a leaking issue with the iv.When the co-signing nurse assessed the iv, she noted it was leaking from the end of the safebreak that connects to the administration line.The glucommander had started increasing the insulin gtt up to a higher dose because the patient's blood sugar was increasing.The nurses removed safebreak from the administration line, reconnected the administration line to the patient's iv and the insulin gtt dose went back down.There was no report of patient injury or additional medical intervention associated with this event.Device was discarded, but the site reported that there were no visible breaks or cracks before discarding.No additional information is available.

• Brand Name: SAFEBREAK VASCULAR
• Common Device Name: SAFEBREAK VASCULAR
• Manufacturer (Section D): LINEUS MEDICAL; 179 north church avenue; suite 202; fayetteville AR 72701
• Manufacturer (Section G): LINEUS MEDICAL; 179 north church avenue; suite 202; fayetteville AR 72701
• Manufacturer Contact: will armstrong ; 179 north church avenue; suite 202; fayetteville, AR 72701 ; 9013612042
• MDR Report Key: 20941489
• Report Number: 3019511659-2024-00001
• Device Sequence Number: 8135209
• Product Code: QOI
• UDI-Device Identifier: 10860635000311
• UDI-Public: 10860635000311
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: DEN190043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2025
• Device Catalogue Number: 2855-01-0001
• Device Lot Number: 11956 ,12025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2023
• 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
• Patient Sex: Unknown