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	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer returned unused samples for investigaiton.Pending final investigation on returned samples.
Event or Problem Description
The customer reported the following : "i am reaching out to you in regard to nipro medical luer adapter pn#367290 ref# lm+20g , in particular, lot # 's 22k29a / 22j11b / 22j14b.I have also come across some failures (breakage) of this product." the reporter believed the first issue noted was sometime in march 2024, but were unable to specify a date.They also noted that it is unknown how many luer adapters are impacted."the adapters are getting stuck in the lumens of the cvc resulting in patient being sent to the emergency room and having the cvc replaced or broken part removed from lumen by a vascular surgeon.Patients are missing dialysis treatment." lot#s in question: 22k29a, 22j11b, 22j14b, 23b27b, 22k09a.

• 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: 20875252
• Report Number: 1056186-2024-00021
• Device Sequence Number: 7851386
• Product Code: FMI
• UDI-Device Identifier: 10383790002391
• UDI-Public: 10383790002391
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: SEE LIST IN SECTION B5
• 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: 12/08/2024
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/08/2024