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	11/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Multiple attempts made to obtain samples; customer responded stating that did not have any samples available.
Event or Problem Description
The reporter noted the following: "a clinical manager reported to fresenius medical care via email that a patient care technician used the luer adapter (luer adapter, 20gx3/4 1bx/100ea) in patient cvc with vacutainer to draw hg.Upon removal, the adapter broke off in the cvc arterial limb and was unable to be removed.The patient was sent out to access center for cvc exchange." no injury to patient, but did have to receive surgical replacement of cvc due to incident.Patient returned to clinic same day and received full dialysis treatment after cvc procedure.

• 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: 20875413
• Report Number: 1056186-2024-00029
• Device Sequence Number: 7804736
• Product Code: FMI
• UDI-Device Identifier: 10383790002391
• UDI-Public: 10383790002391
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/08/2024

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: 22J14B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/19/2024
• Device Age: 2 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/08/2024
• 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; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/08/2024