MAUDE Adverse Event Report: NEXUS MEDICAL, LLC NEXUS TKO®; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N3561
Health Effect - Clinical Code	Missed Dose (2561)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Iv fluids, versed, fentanyl and vecuronium drips infusing via manifold into patients central line.Plastic end piece of manifold found lying in bed broken into several pieces.Iv fluids and drips infusing into the patient's bed.Subsequently, informed of another manifold that fell apart during use but this one was not saved.

• Brand Name: NEXUS TKO®
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): NEXUS MEDICAL, LLC; 11315 strang line road; lenexa KS 66215
• MDR Report Key: 9362318
• Report Number: 9362318
• Device Sequence Number: 19390872
• Product Code: FPA
• UDI-Device Identifier: 10815879020731
• UDI-Public: (01)10815879020731
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2019
• Report Date (Section F): 11/07/2019

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: No Information
• Device Model Number: N3561
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/07/2019