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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMGEN USA, INC. NEULASTA ONPRO KIT; THERMOMETER, ELECTRONIC, CLINICAL

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AMGEN USA, INC. NEULASTA ONPRO KIT; THERMOMETER, ELECTRONIC, CLINICAL Back to Search Results
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Code Available (3191)
Event Date 12/16/2016
Event Type  malfunction  
Event Description
Patient received neulasta onpro kit and noted the following day that his sleeve was soaked where the onpro device was.Patient called the neulasta company to report this.Patient was given a sq injection of neulasta due to losing some of the dose due to the leakage.
 
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Brand Name
NEULASTA ONPRO KIT
Type of Device
THERMOMETER, ELECTRONIC, CLINICAL
Manufacturer (Section D)
AMGEN USA, INC.
12000 plantside dr.
louisville KY 40299
MDR Report Key7959739
MDR Text Key123517781
Report Number7959739
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/21/2018
Event Location Outpatient Treatment Facility
Date Report to Manufacturer10/11/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age20805 DA
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