MAUDE Adverse Event Report: BECTON DICKINSON & CO. BD ULTRA FINE PEN NEEDLE

Model Number 12.7 MM 29

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2014

Event Type  malfunction  

Event Description

I use bd ultra fine pen needles for injecting insulin every night.They are the original size of 12.7mm 29g gauge.They are from lot number 2340131 made in (b)(4).I opened a needle two nights ago and a small, dried up bug fell out of the needle container.I have to say that it happened once before from the same box, but i didn't report it then.Since this is the second time it has happened, i thought i should mention something as it could mean they have a bug problem with a sterile needle.I called the company and told them what happened, but the rep, who answered kept trying to put words in my mouth and say it was the pharmacy's fault.I told her i didn't know, but the lid was on the needle when i pulled it off.She told me that the lid was probably loose and the bug came in at the pharmacy.Then she said she was sending me a gift certificate for a free box.I told her i didn't want anything, i just wanted to tell that there was a bug in the needle.It didn't seem as if they took it too seriously, but she is sending me a box to send in the needle with the bug.

• Brand Name: BD ULTRA FINE PEN NEEDLE
• Type of Device: BD ULTRA FINE PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON & CO.
• MDR Report Key: 3701889
• MDR Text Key: 21809077
• Report Number: MW5035198
• 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: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 12.7 MM 29
• Device Lot Number: 2340131
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 166