droplet® pen needles 31G x 8mmRecalls & reported problems
Htl Strefa S A · 100 pcs sterile, single use droplet® pen needles per box, intended to be used with a pen injector device for the subcutaneous injection of insulin or drugs. · Class 2
All models of droplet pen needles (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
These are droplet pen needles, the short 31G tips used with insulin pens for subcutaneous injections. The 54 reports mostly describe needles bending during injection, sometimes breaking off at the base and staying in the body, plus dull tips, clogged needles, and insulin not dispensing; a few mention bruising or accidental pokes from the cap coming loose. No deaths and no injuries were reported. No recalls name this device, and no reports have come in since 2022.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 54
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 05907996093052), received between Jun 26, 2018 and Dec 15, 2022 — classified as 54 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (27 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
Device problems
- Material Twisted/Bent27
- Infusion or Flow Problem12
- Dull, Blunt9
- Obstruction of Flow5
- Appropriate Device Problem Term/Code Not Available4
- Break1
- Complete Blockage1
- Detachment of Device or Device Component1
Patient problems
- No Information44
- Needle Stick/Puncture2
- No Clinical Signs, Symptoms or Conditions2
- No Code Available2
- No Known Impact Or Consequence To Patient2
- Bruise/Contusion1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2022Break; Break
USER HAS BEEN INJECTING INSULIN FOR OVER 20 YEARS BUT IS NEW TO THE DROPLET BRAND. USER CLAIMS THAT EVERY NEEDLE SHE USED WOULD BEND DURING HER INJECTION, SO THAT EACH PATIENT END OF THE NEEDLE WAS BENT OVER WHEN SHE REMOVED THE NEEDLE. SHE CLAIMS THAT 4 NEEDLES BROKE OFF OF THE PEN NEEDLE BASE AND GOT STUCK IN HER STOMACH AFTER INJECTION. SHE DID NOT SEEK MEDICAL ATTENTION. SHE WAS ABLE TO REMOVE THEM BY CUTTING A SMALL SLIT INTO THE INJECTION SITE TO RETRIEVE THE NEEDLE. PATIENT HAS USED DIFFERENT BRAND NEEDLES BEFORE AND HAS NOT HAD ANY PROBLEMS.
Patient problems: Needle Stick/Puncture
MAUDE report 15988466 ↗MalfunctionMar 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE PATIENT IS A DIABETIC WHO IS PHYSICALLY HANDICAP AND ALSO VISUALLY IMPAIRED. SHE RECENTLY STARTED USING YOUR DROPLET PEN NEEDLES AND HAS FOUND AFTER HER INJECTION, WHEN SHE ATTEMPTS TO REPLACE THE OUTER/LARGER NEEDLE CAP TO COVER THE ACTUAL NEEDLE, THE OUTER CAP DOES NOT STAY SECURE ON THE NEEDLE'S PLASTIC RING. WHEN REMOVING THE NEEDLE FROM THE PEN, THE OUTER CAP FALLS OFF AND A PERSON CAN EASILY BE POKED WITH THE NEEDLE. THIS DOES NOT ONLY HAPPEN TO HER BUT OTHER CAREGIVERS WHO ARE GIVING HER INJECTIONS.
Patient problems: Needle Stick/Puncture
MAUDE report 13822735 ↗MalfunctionMay 31, 2021Infusion or Flow Problem; Infusion or Flow Problem
USER CALLED TO ADVISE THAT IS HAVING FLOW ISSUES WITH 10% OF EVERY BOX THAT HE RECEIVES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11906980 ↗MalfunctionApr 30, 2021Infusion or Flow Problem; Infusion or Flow Problem
THE PATIENT CALLED IN STATING THAT THE PEN NEEDLE CLOGS DURING HIS INJECTION. HE STATED THAT HE HAS BEEN USING DROPLET FOR YEARS AND HAS NEVER HAD AN ISSUE; HOWEVER, WITH THIS BOX THE CLOG HAS HAPPENED 4-5 TIMES THIS WEEK. HE DID NOT WANT TO PROVIDE MEDICAL INFORMATION. HE JUST WANTED TO LET THE ISSUE BE KNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11751897 ↗MalfunctionJan 7, 2020Infusion or Flow Problem; Infusion or Flow Problem
PATIENT RECEIVED 2 BOXES OF DROPLET 31G X 8MM FROM VA WITH LOT NO. Y58S6. HE INJECTS 30 UNITS OF LANTUS ONCE A DAY AND 16-18 UNITS OF NOVOLOG ONCE A DAY WITH THE CORRESPONDING PENS. HE CALLED IN TODAY BECAUSE, HE STATES THAT HIS INSULIN IS NOT DISPENSING WHEN HE TRIES PRIMING THE NEEDLES. SOMEHOW THE NEEDLE IS CLOGGED. HE HAS GONE THROUGH SEVERAL NEEDLES AND THIS HAS HAPPENED MULTIPLE TIMES. HE STATES THAT HE DOES REUSE NEEDLES BUT, THIS HAPPENS ON THE 1ST ATTEMPT TO USE.
Patient problems: No Information
MAUDE report 9556509 ↗MalfunctionDec 20, 2019Material Fragmentation; Material Fragmentation
PATIENT RECEIVED 4 BOXES OF 31G X 8MM PEN NEEDLES WITH LOT NO. S285A FROM THE VA. HE IS USING A DROPLICON PEN TO INSERT 28 UNITS OF LANTUS ONCE PER DAY. HE STATED THAT HE'S HAD 2 PEN NEEDLES BREAK WITHIN THE LAST WEEK AS HE'S TRYING TO INSERT THE NEEDLE INTO HIS ABDOMEN. ONE HE WAS ABLE TO PULL OUT AND THE OTHER IS LOST. HE WENT TO THE ER FOR AN X-RAY; HOWEVER, NOTHING SHOWED UP SO HE DOESN'T KNOW WHERE IT IS. PATIENT STATED HE DOES NOT PINCH UP AS HE'S INJECTING. I ADVISED THAT WITH THE 8MM PEN, HE SHOULD PINCH UP. I SUGGESTED A SMALLER NEEDLE IF HE IS MORE COMFORTABLE WITH NOT PINCHING UP AND HE WAS OPEN. THE LOT NUMBER IS NOT CORRECT. SEVERAL ATTEMPTS WERE MADE ON THE 18TH TO CONTACT THE PATIENT TO GET THE CORRECT LOT, BUT THE PATIENT DID NOT ANSWER NOR HAVE THEY CALLED US BACK. THE USER'S SAMPLES WERE SEND MONTH AGO AND THE LOT NUMBER COULD BE DEFINED-Y58Z5.
Patient problems: Patient Problem/Medical Problem
MAUDE report 9502799 ↗MalfunctionJun 6, 2019Material Twisted/Bent; Material Twisted/Bent
RECENTLY, SEVERAL PATIENTS USING THE DROPLET PEN NEEDLES HAVE EXPERIENCED THE PEN NEEDLES BREAKING OFF IN THEIR ARMS AND BENDING WITH EACH USE.
Patient problems: No Information
MAUDE report 8674028 ↗MalfunctionMay 16, 2019Dull, Blunt; Dull, Blunt
EVERY 3RD OR 4TH NEEDLE IS DULL. HAS TO PUSH TO GET THE NEEDLE TO GO IN.
Patient problems: No Information
MAUDE report 8614690 ↗MalfunctionApr 24, 2019Infusion or Flow Problem; Material Twisted/Bent; Infusion or Flow Problem; Material Twisted/Bent
PEN NEEDLE ARE BENDING AND THE INSULIN FLOW IS NOT ALLOWED.
Patient problems: No Information
MAUDE report 8543795 ↗MalfunctionApr 19, 2019Obstruction of Flow; Obstruction of Flow
PATIENT REPORTS PEN NEEDLES ARE "STOPPED UP". HE WILL START TO INJECT, BUT THE FLOW OF INSULIN STOPS.
Patient problems: No Information
MAUDE report 8530600 ↗MalfunctionApr 18, 2019Obstruction of Flow; Obstruction of Flow
WIFE IS CALLING ON BEHALF OF HUSBAND. SHE GIVES HIS INJECTIONS. DIFFICULTY GETTING THE INSULIN TO EJECT.
Patient problems: No Information
MAUDE report 8526969 ↗MalfunctionApr 18, 2019Obstruction of Flow; Obstruction of Flow
WIFE IS CALLING ON BEHALF OF HUSBAND. SHE GIVES HIS INJECTIONS. DIFFICULTY GETTING THE INSULIN TO EJECT.
Patient problems: No Information
MAUDE report 8526870 ↗MalfunctionFeb 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT REPORTS HAVING ISSUE WITH PEN NEEDLES NOT WORKING.
Patient problems: No Information
MAUDE report 8373143 ↗MalfunctionFeb 26, 2019Material Twisted/Bent; Material Twisted/Bent
PT EXPERIENCING DISCOMFORT FROM NEW NEEDLES AND NEEDLE PEN BENDS.
Patient problems: No Code Available
MAUDE report 8369402 ↗MalfunctionFeb 21, 2019Infusion or Flow Problem; Infusion or Flow Problem
PATIENT REPORTS HAVING TROUBLE WITH THIS PEN NEEDLE. STATES IT ISN'T WORKING RIGHT, NOT DOSING INSULIN CORRECTLY.
Patient problems: No Information
MAUDE report 8356928 ↗MalfunctionFeb 11, 2019Dull, Blunt; Dull, Blunt
PATIENT SAYS THAT HER HUSBAND'S NEEDLES FROM THE (B)(6) ARE BENDING. EVERY 2 OUT OF 10.
Patient problems: No Information
MAUDE report 8324855 ↗MalfunctionFeb 11, 2019Material Twisted/Bent; Material Twisted/Bent
(B)(6) PATIENT CALLED SAYING THAT THE NEEDLES ARE BENDING AND BREAKING OFF AND THAT TWO HAVE BROKEN OFF IN HIS SKIN, HE HAD TO PULL THEM OUT, HE DID NOT NEED TO GO TO DOCTOR.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8324843 ↗MalfunctionFeb 11, 2019Infusion or Flow Problem; Material Twisted/Bent; Infusion or Flow Problem; Material Twisted/Bent
EVERY 4 OUT OF 10 NEEDLES EITHER BEND OR WON'T INJECT HIS MEDICATION.. THE NEEDLES ARE CAUSING HIM TO BRUISE.
Patient problems: Bruise/Contusion
MAUDE report 8324838 ↗MalfunctionFeb 11, 2019Material Twisted/Bent; Material Twisted/Bent
MR. (B)(6) CALLED TO ADVISE THAT APPROXIMATELY 90% OF THE NEEDLES IN BOTH BOXES IS BENDING. THE BEND IS A 45 DEGREE ANGLE.
Patient problems: No Information
MAUDE report 8324830 ↗MalfunctionFeb 11, 2019Material Twisted/Bent; Material Twisted/Bent
PATIENT STATES THE NEEDLE IS TOO SMALL AND IT BENDS.
Patient problems: No Information
MAUDE report 8324819 ↗MalfunctionFeb 11, 2019Dull, Blunt; Dull, Blunt
PT STATES THIS NEEDLE IS NOT AS SHARP AS THE NOVOFINE AND HE IS HAVING A HARD TIME GETTING THE NEEDLE TO BREAK THE SKIN.
Patient problems: No Information
MAUDE report 8324810 ↗MalfunctionFeb 8, 2019Material Twisted/Bent; Material Twisted/Bent
DIFFICULTY BREAKING THE SKIN. NEEDLE BENDS AND LEAKS.
Patient problems: No Information
MAUDE report 8319601 ↗MalfunctionFeb 7, 2019Dull, Blunt; Dull, Blunt
PHARMACIST CALLED COMPLAINING THAT THE PEN NEEDLES ARE BLUNT AND WILL NOT PENETRATE THE SKIN. A FEW PATIENTS HAVE COMPLAINED, BUT ONLY ONE HAS COME INTO THE PHARMACY TO DISCUSS.
Patient problems: No Information
MAUDE report 8314110 ↗MalfunctionJan 21, 2019Infusion or Flow Problem; Infusion or Flow Problem
PATIENT CALLED SAYING THAT THE NON-PATIENT END OF THE NEEDLE WAS OFF-CENTER IN 4 OUT OF A BOX OF 100. NO MEDICINE WOULD FLOW THROUGH.
Patient problems: No Information
MAUDE report 8263594 ↗MalfunctionDec 10, 2018Material Twisted/Bent; Material Twisted/Bent
THE PATIENT IS COMPLAINING OF BENT NEEDLES AS HE GOES TO INJECT.
Patient problems: No Information
MAUDE report 8146008 ↗
Other Needle, Hypodermic, Single Lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page