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 fresenius medical care by a registered nurse that, the nipro adapter break at the neck and get stack in patient catheter exit sites and needles.Turning clockwise makes it go dipper and anticlockwise harder to pull, they breaking at the neck.
Additional Manufacturer Narrative
Multiple attempts were made to obtain additional information and samples.Customer never responded.

• 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: 20873789
• Report Number: 9611446-2024-00005
• Device Sequence Number: 21059047
• Product Code: FMI
• UDI-Device Identifier: 10383790002391
• UDI-Public: 10383790002391
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/07/2024

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: 23A31B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 12/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2023
• 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