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

Model Number BD6010

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2018

Event Type  malfunction  

Event Description

Device leaked blood at the luer lock connector.Manufacturer response for blood collection assembly with male luer lock, nexus (per site reporter).Will pick up.

• Brand Name: IV PLUS®
• Type of Device: SYSTEM, BLOOD COLLECTION, VACUUM-ASSISTED, MANUAL
• Manufacturer (Section D): NEXUS MEDICAL, LLC; 11315 strang line road; lenexa KS 66215
• MDR Report Key: 8288283
• MDR Text Key: 134460975
• Report Number: 8288283
• Device Sequence Number: 1
• Product Code: KST
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BD6010
• Device Lot Number: 18192
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2019
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1