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	10/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Multiple attempts were made to obtain additional information and samples.No response received from the customer.
Event or Problem Description
It was reported to fresenius medical care by a registered nurse that multiple luer adapter breaking away from vacutainer and having removed from dialysis access.The customer provided the following additional information on 12-nov-2024: "the incident occurred on (b)(6) 2024 at clinic (b)(6) and (b)(6)2024 at clinic (b)(6).On (b)(6)2024, there were 3 of the adapters break in the dialysis access.".
Event or Problem Description
It was reported to fresenius medical care by a registered nurse that multiple luer adapter breaking away from vacutainer and having removed from dialysis access.The customer provided the following additional information on (b)(6) 2024: "the incident occurred on (b)(6) 2024 at clinic (b)(6) and (b)(6) 2024 at clinic (b)(6).On (b)(6) 2024, there were 3 of the adapters break in the dialysis access.".
Additional Manufacturer Narrative
Multiple attempts were made to obtain additional information and samples.No response received from the customer.12/07/2024: redvised date of event on section b3.

• 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: 20874141
• Report Number: 1056186-2024-00025
• Device Sequence Number: 8694288
• Product Code: FMI
• UDI-Device Identifier: 10383790002391
• UDI-Public: 10383790002391
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2024
• Report Date (Section F): 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: 23H18B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/04/2024
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/07/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/07/2024
• Supplement Report FDA Received Date: 12/07/2024
• 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; Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/07/2024