MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE PEN NEEDLES - 8MM X 31G - PENTA POINT COMFORT; SYRINGE, PISTON

Device Problems Loose or Intermittent Connection (1371); Product Quality Problem (1506); Difficult to Remove (1528)

Patient Problem Needle Stick/Puncture (2462)

Event Date 06/01/2018

Event Type  No Answer Provided  

Event Description

Recently my prescription plan required me to change from using novolog needles to bd ultra-fine pen needles - short 8mm x 31g.They are used multiple times a day for delivering novolog and lantus insulin.There are design flaws that pose the following risks: higher likelihood of accidently stabbing oneself with an expose needle; contamination of an insulin pen by laving a needle in place of a pen.I noticed a few things about the design of the bd needles.There are three parts to the needle, outer larger cap, inner needle and the needle itself.The method for using is to screw the needle on the insulin pen, remove outer larger cap and the inner needle cap.Then inject the insulin.To remove the needle from the pen, the larger cap is replaced and unscrewed.This last point is where the issue happens.The removing of the needle relies on friction between the larger cap and needle.Frequently i cannot remove the needle from the pen, as the larger cap comes off even though the needle is fully unscrewed.This leaves the needle in place and is a danger to stabbing myself again (which i have).Also, it leaves the needle in place thus potentially contaminating the insulin pen when recapping the pen without noticing the needle being still on.This happens frequently when using these needles with the lantus.Also, the novolog needles had a design that would not allow the user to replace the cap of the pen with the needle (and outer larger cap on the pen).I am able to replace the cap of the pantus pen with the needle assembly still on the pen.Which there is a warning against doing leading to insulin contamination.Two improvements needed: added tightness of the outer cap with the needle thus more friction; larger diameter of the outer cap that will not allow it to fit inside a lantus pen cap.I believe novolog pen achieve this by having a larger rim at the based of the needles outer larger cap.

• Brand Name: BD ULTRA-FINE PEN NEEDLES - 8MM X 31G - PENTA POINT COMFORT
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE
• MDR Report Key: 7586399
• MDR Text Key: 110866351
• Report Number: MW5077717
• 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: 06/06/2018

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?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR