MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP LUER LOCK ACCESS DEVICE

Model Number	ACSD
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This medwatch was received in a paper format via mail from the fda and delivered to an unattended mailbox due to covid-19 workplace policy restrictions.Upon discovery the report was investigated per procedure and the mail receiving process has been modified.User facility medwatch number: (b)(4).It was reported that the nurse noticed leaking from the utilized lumen and upon examination found the protruding blue piece from the luer lock access device lodged in the microclave of the patients picc lumen.No additional details are available related to the customer reported issue.The facility stated all available information was provided in the initial medwatch and is unable or unwilling to provide further incident details to the manufacturer.The sample is not available to be returned for evaluation.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the nurse noticed leaking from the utilized lumen and upon examination found the protruding blue piece from the luer lock access device lodged in the microclave of the patients picc lumen.

• Brand Name: LUER LOCK ACCESS DEVICE
• Common Device Name: LUER LOCK ACCESS DEVICE
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 14712201
• Report Number: 1417592-2022-00081
• Device Sequence Number: 19428061
• Product Code: FMI
• UDI-Device Identifier: 10193489006070
• UDI-Public: 10193489006070
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2022

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 Model Number: ACSD
• Device Catalogue Number: ACSDH
• Device Lot Number: 210414
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 90 KG