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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Samples have been requested from the customer.Factory pending receipt of samples.
Event or Problem Description
It was reported to fresenius medical care by an administrative assistant that the end piece releases and gets stuck when using for blood draws.Blood draws in (b)(6) 2024.(several patients over the course of 2 days).Clinic asked for their staff's preferred adapters made by a different manufacturer for the following order from spectra for the following month.They discontinued using the nipro brand immediately.This month, they received 2 more boxes, which then prompted their complaint.No injury to patient, just delayed completion of treatment due to having to get a doctor to travel here to remove the "cap" lodged in catheter hub.Also was stuck in fistula tubing line.

• 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: 20873859
• Report Number: 1056186-2024-00024
• Device Sequence Number: 12917188
• Product Code: FMI
• UDI-Device Identifier: 10383790002391
• UDI-Public: 10383790002391
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• 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: 22K09A, 22L26B
• 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: 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: 12/07/2024
• 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: Other; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/07/2024