MAUDE Adverse Event Report: NEXUS MEDICAL, LLC IV PLUS VACUTAINER; SYSTEM, BLOOD COLLECTION, VACUUM-ASSISTED, MANUAL

Model Number	BD6010
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	11/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Nurse drawing labs, couldn't draw labs as device cracked and blood leaking.

• Brand Name: IV PLUS VACUTAINER
• Common Device Name: SYSTEM, BLOOD COLLECTION, VACUUM-ASSISTED, MANUAL
• Manufacturer (Section D): NEXUS MEDICAL, LLC; 11315 strang line road; lenexa KS 66215
• MDR Report Key: 8128157
• Report Number: 8128157
• Device Sequence Number: 11155392
• Product Code: KST
• UDI-Device Identifier: 10815879021011
• UDI-Public: (01)10815879021011
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/30/2018
• Report Date (Section F): 11/30/2018

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: BD6010
• Device Lot Number: 18031
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/04/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2018
• 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: 11/30/2018