MAUDE Adverse Event Report: U-100 INSULIN SYRINGE (SIZE 50CC)

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 06/14/2018

Event Type  malfunction  

Event Description

I was attempting to enter air into a vial of insulin with a syringe, and the syringe came apart.The needle portion separated from the body.The needle portion then flew into the air and landed at my feet.(b)(6).

• Brand Name: U-100 INSULIN SYRINGE (SIZE 50CC)
• Type of Device: U-100 INSULIN SYRINGE (SIZE 50CC)
• MDR Report Key: 7609583
• MDR Text Key: 111490498
• Report Number: MW5077905
• 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: Patient
• Type of Report: Initial
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 127