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

Device Problems Structural Problem (2506); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

Patient stated a couple of the needles she received malfunctioned.She stated 1 needle was bent and other was short but still worked.No further details provided.The exact therapy start date is unknown, the shipment month has been provided as an estimate.

• Brand Name: PEN INJ
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): ELI LILLY AND COMPANY PHARMACEUTICAL DELIVERY SYSTEMS
• MDR Report Key: 7960431
• MDR Text Key: 124878173
• Report Number: MW5080519
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/03/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/11/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 48