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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY SYSTEMS HUMULIN KWIKPEN; SYRINGE, PISTON
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ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY SYSTEMS HUMULIN KWIKPEN; SYRINGE, PISTON Back to Search Results
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/16/2020
Event Type  malfunction  
Event Description
Humulin n kwik pen no.(b)(4), exp.01 2022 when administering the nph dose of 30 units, the insulin pen was sluggish to deliver dose and the dial only went from 30 to 16 instead of zero for complete dose delivery.Attempted to place new needle to finalize dose and discovered a bulge where the rubber is punctured by the needle on the insulin pen.Unsure if patient received any insulin.Discussed incident with pharmacist, and obtained a new insulin pen.Discussed incident with dcs sx and obtained new order for 20 nph to be administered to patient.This was finally able to be given to patient by the time multiple phone calls were made and when the new pen arrived to unit.Photo image taken and available if required.
 
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Brand Name
HUMULIN KWIKPEN
Type of Device
SYRINGE, PISTON
Manufacturer (Section D)
ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY SYSTEMS
lilly corporate center
indianapolis IN 46285
MDR Report Key10183509
MDR Text Key196071793
Report Number10183509
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/19/2020
Event Location Hospital
Date Report to Manufacturer06/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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