MAUDE Adverse Event Report: BECTON DICKINSON BD NANO PEN NEEDLES 2ND GENERATION; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 0.23MM X 4MM (32G X 5/32")

Device Problems Fail-Safe Problem (2936); Material Twisted/Bent (2981)

Patient Problems Hemorrhage/Bleeding (1888); Needle Stick/Puncture (2462)

Event Date 02/27/2023

Event Type  malfunction  

Event Description

Using the bd brand nano 2nd gen pen needles for insulin shot administered to my spouse, upon placing the protective plastic cap back onto the needle after use, i did not noticed that the needle had become slightly bent to the side and when placing the plastic protector cap back onto the nano needle to safely dispose of, the needle pierced through the plastic protector cap which i had not noticed resulting in my index finger becoming pricked and bleeding.

• Brand Name: BD NANO PEN NEEDLES 2ND GENERATION
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 16468286
• MDR Text Key: 310680918
• Report Number: MW5115373
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 0.23MM X 4MM (32G X 5/32")
• Device Lot Number: 2180163
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2023
• Patient Sequence Number: 1
• Patient Sex: Female