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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMGEN /INSULET CORP. NEULASTA ONPRO KIT; INTRODUCER, SYRINGE, NEEDLE - ONBODY INJECTOR
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AMGEN /INSULET CORP. NEULASTA ONPRO KIT; INTRODUCER, SYRINGE, NEEDLE - ONBODY INJECTOR Back to Search Results
Health Effect - Clinical Codes Itching Sensation (1943); Burning Sensation (2146)
Date of Event 06/10/2016
Type of Reportable Event Serious Injury
Event or Problem Description
Pt returned to pharmacy day after nurse put on her neulasta onpro kit.She complained that the area around the autoinjector felt hot and itchy.She says it reminds her of a skirt reaction when she got acrylic nails at her salon.The auto injector was not due to inject the drug for 6 more hours but when we removed it from her arm, the medication level looked empty and the adhesive area around the autoinjector was wet.We asked pt if she felt an injection but she was unsure because of the stinging and heat coming from "around the patch." dose or amount: 6 mg, once a month after, route: intravenous (not otherwise specified).Dates of use: (b)(6) 2016.Diagnosis or reason for use: decreases the incidence of infection and febrile neutropenia.
 
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Brand Name
NEULASTA ONPRO KIT
Common Device Name
INTRODUCER, SYRINGE, NEEDLE - ONBODY INJECTOR
Manufacturer (Section D)
AMGEN /INSULET CORP.
MDR Report Key7922406
Report NumberMW5080220
Device Sequence Number1540195
Product Code KZH
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Pharmacist
Type of Report Initial
Report Date (Section B) 09/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Other
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2018
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date09/28/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age57 YR
Patient Weight70
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