MAUDE Adverse Event Report: NIPRO MEDICAL INDUSTRIES (NMI) NIPRO LUER ADAPTER

Model Number	LM+20G-1M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical educator stated that several needles break off into catheter lumens when obtaining lab work on patients.It's not the actual needle.It's the tip of vacutainer that goes inside the catheter lumen that gets stuck inside and breaks off when trying to remove.Clinical educator also mentioned that a patient was involved and required medical intervention to replace the catheter.
Additional Manufacturer Narrative
Changes in company staff caused the medwatch report to be inadvertently submitted late.

• Brand Name: NIPRO LUER ADAPTER
• Common Device Name: LUER ADAPTER
• Manufacturer (Section D): NIPRO MEDICAL INDUSTRIES (NMI); 2-19-64, matsubara; tatebayashi-shi, gunma 374-8 518; JA 374-8518
• MDR Report Key: 22909450
• Report Number: 1056186-2025-00017
• Device Sequence Number: 9089590
• Product Code: FMI
• UDI-Device Identifier: 10383790002391
• UDI-Public: 10383790002391
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2025
• Report Date (Section F): 08/27/2025

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 Model Number: LM+20G-1M
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/02/2024
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/27/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2025
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/27/2025