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	Malfunction
Additional Manufacturer Narrative
Changes in company staff caused the medwatch report to be inadvertently submitted late.
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.

• 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
• Manufacturer (Section G): NIPRO MEDICAL INDUSTRIES (NMI); 2-19-64, matsubara; tatebayashi-shi, gunma 374-8 518; JA 374-8518
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 22909385
• Report Number: 9611446-2025-00003
• Device Sequence Number: 15479490
• Product Code: FMI
• UDI-Device Identifier: 10383790002391
• UDI-Public: 10383790002391
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K992729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown