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U.S. Department of Health and Human Services

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

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CARDIOVASCULAR SYSTEMS INCORPORATED VIPERSLIDE CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
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).
 
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Brand NameVIPERSLIDE
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS INCORPORATED
MDR Report Key13711636
MDR Text Key286999943
Report NumberMW5107975
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Number of Events Reported1
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  
0 Patients were Involved in the Event:
Date FDA Received03/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Model NumberVPR-SLD2
Device Lot Number10PC7322
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided

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