droplet®, pen needles 31G x 8 mmRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05907996099405), received between Aug 4, 2021 and Apr 20, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2023Fluid/Blood Leak; Material Twisted/Bent; Fluid/Blood Leak; Material Twisted/Bent

  PATIENT CALLED ON 03/17/2023 AT 1:51 PM AND LEFT A VOICEMAIL. SPECIALIST WAS ABLE TO CONTACT THE PATIENT ON 03/20/2023 AT 2:35 PM. PATIENT RECEIVED 1 BOX OF DROPLET PEN NEEDLES 31G X 8MM FROM THE VA WITH LOT NUMBER: B46E6. PATIENT HAS USED DROPLET PEN NEEDLES BEFORE AND HAS NOT HAD ANY ISSUES. PATIENT CLAIMS THAT MANY OF THE PEN NEEDLES ARE BENDING AS HE ATTEMPTS HIS STOMACH INJECTION. HE CLAIMS THAT THE PEN NEEDLES ARE BENDING AT THE BASE OF THE PEN NEEDLE, CLOSER TO WHERE THE PEN NEEDLE ATTACHES TO THE INSULIN PEN. PATIENT CLAIMS THAT, FOR THE INJECTIONS WHERE THE PEN NEEDLE BENDS, ROUGHLY HALF OF THE INSULIN DOES NOT ENTER HIS BODY. INSTEAD, IT DRIPS DOWN THE OUTSIDE OF HIS SKIN. PATIENT CLAIMS THAT HE HAS NOT BEEN ABLE TO COMPLETE ALL OF HIS INJECTIONS. PATIENT REPORTS THAT HIS BLOOD SUGAR HAS BEEN MUCH HIGHER AS A RESULT. PATIENT ATTEMPTED TO SPEAK TO THE PHARMACY ABOUT THIS ISSUE, AND THE PHARMACY DIRECTED HIM TO CALL HTL. PATIENT HAS NOT SEEN HIS PRIMARY CARE PHYSICIAN SINCE HIS PEN NEEDLES STARTED BENDING, BUT HE CLAIMS TO HAVE AN APPOINTMENT WITH HIS DOCTOR SOON WHERE HE INTENDS TO DISCUSS THE ISSUE WITH THE DOCTOR. PATIENT INJECTS 4 TIMES PER DAY. PATIENT INJECTS 3 TIMES

  Patient problems: Hyperglycemia

  MAUDE report 16774554 ↗
• MalfunctionAug 4, 2021Material Fragmentation; Material Twisted/Bent; Material Fragmentation; Material Twisted/Bent

  THE PATIENT CALLED IN TODAY STATING THAT HIS PEN NEEDLE IS BENDING AND BREAKING EACH TIME HE INJECTS. OVER THE LAST 3-5 MONTHS HE HAS HAD 8-12 PN BREAK OFF INTO HIS SKIN. HE ALTERNATES INJECTION SITES AND NO MATTER WHERE HE STICKS, THE PN BREAKS. HIS LAST 2 PN BROKE OFF. MOST TIMES HE CAN PULL THE BROKEN NEEDLES OUT OF THE INJECTION SITE BUT A COUPLE OF TIMES HE WAS UNABLE TO FIND IT. HE DOESN'T FEEL DISCOMFORT SO HE IS UNSURE IF ITS IN HIS ABDOMEN OR JUST FALLEN AND LOST SOMEWHERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12273087 ↗