MAUDE Adverse Event Report: ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY HUMALOG QUICK PEN; SYRINGE, PISTON

Lot Number D5574060

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 01/17/2023

Event Type  malfunction  

Event Description

When rn opened the insulin needle, found old needle still stuck on the insulin pen.

• Brand Name: HUMALOG QUICK PEN
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY
• MDR Report Key: 16226156
• MDR Text Key: 308030192
• Report Number: MW5114434
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/19/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: D5574060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/20/2023
• Patient Sequence Number: 1