MAUDE Adverse Event Report: NICO CORPORATION NICO FLUID SYSTEM; SYRINGE, IRRIGATING (NON DENTAL)

Model Number NN-8015

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 10/02/2019

Event Type  malfunction  

Event Description

After priming the fluid irrigation nico system, several holes were discovered after water began to spray around the room soaking the surgeon scrub nurse and surgical field.After disposing of the first disposable of this, a second one was opened up to the surgical field and this second one had holes in the fluid irrigation system spraying and soaking the surgeon scrub nurse and surgical field.This is a disposable that we have had for quite some time and use it a couple times a month at least.The scrub in the case has used this supply/disposable before and even after opening a second one it happened once again and saturated the field, surgeon and scrub.

• Brand Name: NICO FLUID SYSTEM
• Type of Device: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): NICO CORPORATION; 250 e 96th st ste 125; indianapolis IN 46240
• MDR Report Key: 9171556
• MDR Text Key: 161696152
• Report Number: 9171556
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NN-8015
• 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: 10/02/2019
• Date Report to Manufacturer: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21535 DA