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	Foreign Body In Patient (2687)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending final investigation on returned samples.
Event or Problem Description
The reporter noted the following: "luer adapters are breaking off in the chest catheters used to dialyze the patient.When we try to remove the plastic, it gets stuck and when we attempt to removed the plastic then it is commonly breaking in the catheter.This has happened 5 times this week (b)(6) 2024 and has led to 1 patient being sent to the er because we couldn't remove the plastic." dates of occurrences: 1 on monday (b)(6) 2 on tuesday (b)(6) 3 on thursday (b)(6) only one occurrence on (b)(6) resulted in patient going to hospital to have cvc replaced.The reporter does not have further updates on the patient.The reporter stated that all of these occurred while attempted to draw labs from cvc.They were slightly twisting off the adapter when it broke off leaving part of the adapter attached to the patient's cvc.

• 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: 20392819
• Report Number: 1056186-2024-00017
• Device Sequence Number: 15102393
• Product Code: FMI
• UDI-Device Identifier: 10383790002391
• UDI-Public: 10383790002391
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/07/2024
• Report Date (Section F): 10/07/2024

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: 22J14B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/12/2024
• Device Age: 2 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/07/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/07/2024
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/07/2024