MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED VIPERSLIDE; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number VPR-SLD2

Device Problems Device Markings/Labelling Problem (2911); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 12/11/2021

Event Description

I am reviewing a near miss error where viperslide cardiac lubricant was inadvertently stocked in our nicu omnicell for lntralipid 20%.The nurse caught the wrong product prior to administration with barcode validation.Because more than one bag was stocked during an omnicell fill the wrong product barcode was not caught during the filling process because only one item needs to be scanned with safety stock.Would like to report as a look a like issue if a lubricant accidently makes it to pharmacy and placed in a lipid bin.The event was reported in our neonatal intensive care unit (nicu) on xx/xx/2021.It is located at one of our regional medical center that is 378 beds total with 32 beds in the nicu.The viperslide product is stored in a drawer in the operating room and the fat emulsion is stored in two nicu adcs.Photos and the safety update i sent to staff are located in the attachment.I have also notified the manager of our cath lab where the viperslide is stocked.Similar labels/packaging drug distribution system: system failure; (b)(6).

• Brand Name: VIPERSLIDE
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED
• MDR Report Key: 13711636
• MDR Text Key: 286999943
• Report Number: MW5107975
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/04/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: VPR-SLD2
• Device Lot Number: 10PC7322
• Patient Sequence Number: 1