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	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to customer service of fresenius medical care that the end of the adapter that goes into the patient's cvc broke off in the cvc lumen.This occurred at the patient's home when the care partner/wife was obtaining monthly lab work.The end of the lumen that goes into the pt's catheter got stuck in the end of the pt's lumen.Care partner reports that she had to wiggle it back and forth for several minutes before it released.No injury to the patient.It did not break off as previously thought.
Additional Manufacturer Narrative
Customer returned unused samples for investigaiton.Pending final investigation on returned samples.
Event or Problem Description
It was reported to customer service of fresenius medical care that the end of the adapter that goes into the patient's cvc broke off in the cvc lumen.This occurred at the patient's home when the care partner/wife was obtaining monthly lab work.The end of the lumen that goes into the pt's catheter got stuck in the end of the pt's lumen.Care partner reports that she had to wiggle it back and forth for several minutes before it released.No injury to the patient.It did not break off as previously thought.
Additional Manufacturer Narrative
Customer returned unused samples for investigaiton.Pending final investigation on returned samples.

• 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: 20875287
• Report Number: 9611446-2024-00011
• Device Sequence Number: 15632425
• Product Code: FMI
• UDI-Device Identifier: 10383790002391
• UDI-Public: 10383790002391
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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: 22K09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 12/08/2024
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown