MAUDE Adverse Event Report: BECTON DICKINSON BD NANO PEN NEEDLES

Model Number NANO

Device Problem Leak/Splash (1354)

Patient Problem Underdose (2542)

Event Date 01/01/2016

Event Type  Injury  

Event Description

Pen needles/bd nano brand does not seal properly.When you inject insulin, a portion leaks out so your not getting full dosage.You never know if you're getting the right dosage.

• Brand Name: BD NANO PEN NEEDLES
• Type of Device: BD NANO PEN NEEDLES
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 5503676
• MDR Text Key: 40542575
• Report Number: MW5060903
• Device Sequence Number: 1
• Product Code: FMI
• 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: 03/11/2016

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 Operator: Lay User/Patient
• Device Model Number: NANO
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 89