MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; LUER LOCK ACCESS DEVICE

Model Number	ACSD
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the onguard luer lock access device was hemolyzing blood samples as well as not drawing blood samples which required the nurse to use a syringe on the patient to obtain a blood sample.No additional details are available related to the customer reported issue.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the onguard luer lock access device was hemolyzing blood samples as well as not drawing blood samples which required the nurse to use a syringe on the patient to obtain a blood sample.

• Brand Name: MEDLINE
• Common Device Name: LUER LOCK ACCESS DEVICE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11345126
• Report Number: 1417592-2021-00022
• Device Sequence Number: 4997609
• Product Code: FMI
• UDI-Device Identifier: 10193489006070
• UDI-Public: 10193489006070
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/18/2021

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: Health Professional
• Device Model Number: ACSD
• Device Catalogue Number: ACSD
• Device Lot Number: 200715
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 02/18/2021
• 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