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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOVASCULAR SYSTMS, INC. VIPERSLIDE IV BAG 100 ML CATHETER, PERIPHERAL, ATHERECTOMY

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CARDIOVASCULAR SYSTMS, INC. VIPERSLIDE IV BAG 100 ML CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  No Answer Provided  
Event Description
An iv bag was returned to the pharmacy which was assumed to be fat emulsion, but upon reading the label, it was discovered to be a lubricant for a piece of equipment for used in our cv lab (for peripheral orbital atherectomy). The product is called viperslide and is sold in a plastic bag with two ports and looks very similar to our iv fat emulsion bags. The tech returning the stock caught it before it was placed in the fat emulsion stock. Severity: circumstances or events have capacity to cause error. Ismp,(b)(6), access number: (b)(4).
 
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Brand NameVIPERSLIDE IV BAG 100 ML
Type of DeviceCATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
CARDIOVASCULAR SYSTMS, INC.
MDR Report Key8231400
MDR Text Key132912966
Report NumberMW5082970
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 01/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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