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
The reporter noted the following: "adapters have broken off inside 2 catheter hubs and 1 fisltula needle line when atempting to remove after blood draws.Float staff at unit on these days report seeing this happen at other units in the area.Unsure if those events were reported.".The customer noted they had 2 lots: 23b27b, 22k09a.However, they were unsure which 1 had the issue.They reported no injury to patients (3) as they were able to retrieve the broken fragments.Also, the reporter noted the following: "staff working in our float pool reported to me that they have seen this happening at other clinics that they work at.".
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
• MDR Report Key: 20875047
• Report Number: 1056186-2024-00026
• Device Sequence Number: 8800964
• Product Code: FMI
• UDI-Device Identifier: 10383790002391
• UDI-Public: 10383790002391
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 12/08/2024
• 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: 23B27B, 22K09A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/08/2024
• Device Age: 2 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/07/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2024
• 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: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/07/2024