droplet® pen needle 32G x 4mmRecalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 05907996092697), received between Aug 13, 2018 and Jul 24, 2025 — classified as 1 injury, 39 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (10 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 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2025Fluid/Blood Leak; Material Integrity Problem; Material Twisted/Bent; Fluid/Blood Leak; Material Integrity Problem; Material Twisted/Bent

  ON 07/07/2025, HTL-STREFA INC. RECEIVED AN EMAIL COMPLAINT. CUSTOMER STATED: I RECEIVED A BOX OF NEEDLES FROM A MILITARY BASE PHARMACY. THE NEEDLES ARE DEFECTIVE. I'VE BEEN USING THEM AND NOT KNOWING THAT DURING INJECTION, MOST OF THE INSULIN WAS NOT BEING INJECTED CORRECTLY BUT BEING SHOT OUT FROM THE SIDE AND THE NEEDLES WERE BENDING. I'VE BEEN INJECTING FOR SEVERAL YEARS AND THE NEEDLES NEVER BENT UNTIL I STARTED USING FROM THIS BOX. I'VE USED ABOUT HALF THE BIX AND STOPPED USING THEM. DURING THIS TIME MY BLOOD SUGAR WAS NOT DECREASING BY MUCH WHEN I WOULD INJECT MYSELF. IF IT WEREN'T FOR MY WIFE NOTICING WHAT WAS HAPPENING WITH THESE NEEDLES, I PROBABLY WOULD STILL BE USING THEM. THIS NEEDS TO BE LOOKED INTO. THANK YOU. NO SAMPLE HAS NOT BEEN RETURNED TO HTL-STREFA FOR FURTHER EVALUATION. HTL-STREFA S.A. MADE A MULTIPLE ATTEMPTS TO OBTAIN DETAILED INFORMATION TO THE EVENT CIRCUMSTANCES. WITHOUT RESULTS.

  Patient problems: Hyperglycemia; Insufficient Information

  MAUDE report 22585431 ↗
• MalfunctionJun 6, 2023Fluid/Blood Leak; Dull, Blunt; Fluid/Blood Leak; Dull, Blunt

  HOLD FOR TH. 6.8 THE CALLER CALLED ON 05/15/2023 AT 10:47 AM AND LEFT A MESSAGE. SPECIALIST SPOKE WITH THE CALLER AT 11:53 AM. THE COMPLAINANT CALLED ON BEHALF OF HER SON, WHO IS THE PATIENT. THE PATIENT RECEIVED 2 BOXES OF DROPLET PEN NEEDLES 32G X 4MM, LOT NUMBERS C58R7 AND C58S4, FROM RITE-AID. PATIENT IS NEW TO THE DROPLET BRAND. PATIENT HAS BEEN INJECTING INSULIN FOR ABOUT ONE YEAR. PATIENT PREVIOUSLY USED BD NANO PEN NEEDLES, AND PATIENT EXPERIENCED NO DIFFICULTIES WITH THE BD NEEDLES. PATIENT CLAIMS THAT THE NEEDLES ARE DULL, AS THOUGH THERE ARE BURRS OR HOOKS ON THE NEEDLE. PATIENT CLAIMS THAT IT TAKES NOTICEABLE MORE PRESSURE TO GET THE NEEDLE TO PIERCE THE SKIN. OCCASIONALLY, SOME OF THE INSULIN LEAKS OUT OF THE SKIN. THE CALLER NOTES THAT THE PATIENT'S BLOOD SUGAR HAS BEEN HIGH LATELY, SO SHE IS UNSURE IF THE PATIENT IS RECEIVING HIS FULL DOES OF INSULIN. THEY HAVE NOT SOUGHT MEDICAL ATTENTION OR GUIDANCE FOR THIS ISSUE AS OF YET. THE PATIENT CLAIMS THAT THE INJECTIONS ARE PAINFUL AND THAT THEY TEAR HIS SKIN. PATIENT CLAIMS THAT THERE IS A WELT AT THE INJECTION SITE AS WELL. PATIENT INJECTS 4 TIMES PER DAY INTO HIS ABDOMEN. PATIENT INJECTS 8-11 UNITS OF NOVOLOG INSULIN 2

  Patient problems: Hyperglycemia; Pain; Skin Tears

  MAUDE report 17074270 ↗
• MalfunctionApr 14, 2023Material Fragmentation; Material Fragmentation

  PATIENT CALLED ON (B)(6) 2023 AT 11:56 AM AND LEFT A VOICEMAIL. THE PATIENT CLAIMS THAT, WHILE USING DROPLET PRODUCTS ON THE NIGHT OF (B)(6) 2023, 2 NEEDLES OR SYRINGES "SCRATCHED HER SKIN" AND ONE "BROKE OFF [INSIDE HER STOMACH]". PATIENT THEN CALLED FOR AN AMBULANCE. THE AMBULANCE ARRIVED AT THE PATIENT'S HOUSE, AND A PARAMEDIC OR EMS PROFESSIONAL REMOVED THE NEEDLE FROM HER STOMACH. PATIENT CLAIMS THAT SHE WILL REPORT THIS INCIDENT TO THE FDA. SPECIALIST ATTEMPTED TO CONTACT THE PATIENT ON 03/14/2023 AT 2:15 PM, BUT WAS UNABLE TO SPEAK WITH THE PATIENT. SPECIALIST LEFT A VOICEMAIL REQUESTING THAT THE PATIENT CALL HIM BACK. SPECIALIST ATTEMPTED TO CONTACT THE PATIENT ON 03/15/2023. SPECIALIST DID NOT GET INTO CONTACT WITH THE PATIENT AND LEFT A VOICEMAIL REQUESTING THAT THE PATIENT RETURN HIS PHONE CALL, SPECIALIST WAS ABLE TO CONTACT THE PATIENT ON (B)(6) 2023. PATIENT RECEIVED 2 BOXES OF DROPLET PEN NEEDLES 32G X 4MM FROM AMAZON WITH LOT NUMBER: C58S6. PATIENT IS NEW TO THE DROPLET BRAND, AND PATIENT HAS BEEN INJECTING FOR 12 YEARS WITH THE "NANO" PEN NEEDLES. SPECIALIST ASKED IF PATIENT USED THE BD NANO NEEDLES, BUT THE PATIENT WAS UNSURE OF THE BRAND NAME. THE PATIENT HAS NEV

  Patient problems: Bruise/Contusion; Foreign Body In Patient

  MAUDE report 16741330 ↗
• MalfunctionDec 21, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent

  PATIENTS MOTHER CALLED IN TODAY BECAUSE, HER (B)(6) DAUGHTER HAS HAD SEVERAL ISSUES SINCE SWITCHING FROM ANOTHER BRAND TO DROPLET. HER ISSUES ARE AS FOLLOWED: SHE IS UNABLE TO UNSCREW THE PN FROM THE PEN WITHOUT THE USE OF HER FINGERS. THIS HAS HAPPENED 100/100X. 2/100 THE PN HAD BROKEN OFF INTO THE PENS HUB. 4/100 THE PN HAS BENT UPON INJECTING WHICH PREVENTS INSULIN FLOW. WE WENT OVER THE IFU AND SHE STATES SHE IS DOING IT CORRECTLY AND NEVER HAD SUCH ISSUES WITH ANOTHER BRAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13051953 ↗
• MalfunctionAug 19, 2021Leak/Splash; Improper Flow or Infusion; Leak/Splash; Improper Flow or Infusion

  LAST NIGHT MY 15U (150UL AT 100UPER ML) PEN INJECTION USING PEN NEEDLES WAS NOT INJECTED S.C. I OBSERVED A POOL OF LIQUID AT THE SKIN SURFACE. REPEATED INJECTION WITH A NEW DROPLET PEN NEEDLES AND SAME LIQUID POOLING WAS NOTED. I REPLACED THE DROPLET NEEDLES A THIRD TIME AND AGAIN OBSERVED A LIQUID POOL ON MY SKIN AT THE INJECTION SITE. ALL PEN NEEDLE INJECTIONS WERE INSERTED TO THE FULL 4MM DEPTH S.C. BEFORE DEPRESSING PLUNGER SLOWLY AND WAITING OVER 15 SECONDS TO WITHDRAW PEN NEEDLE AFTER DOSING. IT APPEARED NO LANTUS INSULIN WAS INJECTED BASED ON VOLUME OF LIQUID POOLING ON SKIN AT INJECTION SITE. PROBLEM WITH DROPLET NEEDLES. SOME (POSSIBLE ALL) HAVE RESTRICTED INNER DIAMETER AND DO NOT DELIVER DOES S.C. OTHER APPEAR TO LEAK AT PLASTIC PEN NEEDLE TIP. THE FULL DOSE IS NOT BEING DOSED S.S. BUT IT IS NOT COMING BACK OUT OF THE SUB CUTANEOUS TISSUE. IT APPEARS TO BE LEAKING FROM PEN NEEDLE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340990 ↗
• MalfunctionJan 18, 2021Failure to Prime; Dull, Blunt; Failure to Prime; Dull, Blunt

  PATIENT CALLED IN REGARDING AN ISSUE SHE IS HAVING WITH A BOX OF PEN NEEDLES. SHE HAS BEEN USING OUR NEEDLES FOR SEVERAL YEARS TO INJECT HER MOTHER WITH NO ISSUES, UNTIL THIS PARTICULAR BOX. INJECTING 25 UNITS, 2 TIMES PER DAY. SHE IS STATING THE NON-PATIENT END OF THE NEEDLE BREAKS/BENDS SOMETIMES WHEN SCREWING ON THE PEN. WHEN THE NEEDLE BREAKS, SHE HAS TO PULL THE NEEDLE OUT OF THE PEN TO PUT ON ANOTHER PEN NEEDLE. WHEN SHE PRIMES, MOST OF THE TIME THE PEN DOESN'T PRIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11185076 ↗
• MalfunctionNov 23, 2020No Flow; No Flow

  THE PATIENT STATED THAT SHE HAS TO SWITCH 2-3 NEEDLES TO GET ONE TO WORK (FOR INSULIN TO COME OUT). THE PATIENT STATED THAT PREVIOUS FILLS FOR THIS DID WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10883752 ↗
• MalfunctionNov 23, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE PATIENT STATED PEN NEEDLES DO NOT STAY ON THE END OF THE PEN. WHEN HE DOES GET TO ATTACH, SOMETIMES THE MEDICATION DOES NOT ADMINISTER SO HE HAS TO CHANGE THE NEEDLE AND STICK HIMSELF AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10883550 ↗
• MalfunctionSep 21, 2020Infusion or Flow Problem; Infusion or Flow Problem

  PATIENT SAID IN TODAY BECAUSE HE MUST USE 4 TO 5 PN TO COMPLETE 1 INJECTION. HE HAS BEEN USING DROPLET FOR 3 MONTHS, AND USED OTHER BRAND PREVIOUSLY. HE STATED THAT DURING THE INJECTION, THE PEN WILL JUST STOP DISPENSING THE INSULIN RESULTING IN THE PATIENT HAVING TO NOT ONLY SWITCH PN SEVERAL TIMES BUT, STICK HIMSELF MORE THAN ONCE. HE STATED THIS HAPPENS OFTEN, BUT COULD NOT PROVIDE A CERTAIN AMOUNT. THE PATIENTS' BLOOD SUGAR REGISTERS HIGH SINCE USING THIS PRODUCT, WHICH IS UNUSUAL FOR HIM, AS THIS NEVER HAPPENED WITH OTHER BRAND. PATIENT DOES NOT REUSE PN, AND THEY ARE NOT BENT IN ANY WAY WHEN THEY ARE REMOVED.

  Patient problems: Hyperglycemia

  MAUDE report 10558600 ↗
• MalfunctionAug 31, 2020Infusion or Flow Problem; Material Twisted/Bent; Infusion or Flow Problem; Material Twisted/Bent

  NEEDLE ON PEN NEEDLE CAP BENDS AND DOES NOT DELIVER INSULIN. OUR PHARMACY JUST CHANGED MANUFACTURERS AND HAVE RECEIVED TWO SEPARATE COMPLAINTS. THE PROBLEM PRODUCT IS: DROPLET PEN NEEDLES, 100 IN A BOX, .23MM X 4MM 32GAUGE X 5/32IN. LOT#Z58K5. "EXP DATE: 20240601".

  Patient problems: No Information

  MAUDE report 10470145 ↗
• MalfunctionAug 27, 2020Infusion or Flow Problem; Infusion or Flow Problem

  PATIENT RECEIVED 1 BOX OF DROPLET 32G X 4MM PN WITH LOT NO Z56T8. HE HAS NOT REPLIED WITH THE RX HE IS INJECTING NOR THE AMOUNT AT THIS TIME. HE INITIALLY EMAILED IN MARCH 2020 REGARDING ISSUES WITH HIS PRODUCT. HE ADVISED THAT THE NEW PRODUCT (REPLACED) IS STILL GIVING HIM ISSUES. DURING HIS INJECTION, HE CAN NO LONGER PRESS DOWN ON THE INJECTOR BUTTON RESULTING IN HIM NOT RECEIVING THE FULL INJECTION FROM THAT PN. HE DOES NOT REUSE PN AND WAS SWITCHED TO THE DROPLET PRODUCT FROM OTHER MARK.

  Patient problems: No Information

  MAUDE report 10458595 ↗
• MalfunctionMay 15, 2020Material Fragmentation; Dull, Blunt; Material Twisted/Bent; Material Fragmentation; Dull, Blunt; Material Twisted/Bent

  THE PATIENT LOSS 18 UNITS OF INSULIN DUE TO THE PN BREAKING OFF INTO HER BELLY. PATIENT SAID MEDICAL ATTN WAS NOT REQUIRED BECAUSE, SHE WAS ABLE TO REMOVE IT AS A SPLINTER. THE PEN NEEDLES ARE DULL AND PAINFUL CAUSING BRUISING. THE PEN NEEDLES BEND AT THE INJECTION SITE, AND THE LABELS HAD FALLEN OFF SEVERAL OF THE PNS (3 THUS FAR). SHE DOES NOT REUSE PEN NEEDLES AND SHE INJECTS STRAIGHT IN OPPOSED TO PINCHING UP.

  Patient problems: Missing Value Reason

  MAUDE report 10060280 ↗
• MalfunctionApr 16, 2020Mechanical Problem; Mechanical Problem

  USER RECEIVED 2 BOXES PEN NEEDLE FROM SAVE ON PHARMACY WITH LOT NO. Z58R2. SHE INJECTS 40 UNITS OF TOJEO 1X PER DAY WITH THE CORRESPONDING PEN. SHE CALLED IN STATING THAT PN 'CAME APART IN HER SIDE.' SHE SAID IT WAS HARD TO INJECT THE PN. WHEN SHE REMOVED PULLED BACK, THE PN WAS STICKING OUT THE SIDE OF HER STOMACH. SHE HAD TO PULL IT OUT WITH HER FINGERS. SHE DOES NOT REUSE PNS.

  Patient problems: No Code Available

  MAUDE report 9966351 ↗
• MalfunctionFeb 5, 2020Infusion or Flow Problem; Infusion or Flow Problem

  USER RECEIVED 1 BOX OF DROPLET 32G X 4MM PNS WITH LOT NO. Z58M5 FROM HUMANA. SHE IS INJECTING LEVIMERE 9 UNITS 1X PER DAY WITH THE CORRESPONDING PEN. SHE CALLED IN STATING THE INSULIN IS GETTING STUCK IN THE PN. SHE HAS TO CHANGE OUT THE PN MULTIPLE TIMES IN ORDER TO GET THE INSULIN TO DISPENSE. SHE DOES PRIME THE PN AND EVEN IN DOING SO, SOMETIMES NOTHING COMES OUT.

  Patient problems: No Information

  MAUDE report 9669699 ↗
• MalfunctionJan 20, 2020Obstruction of Flow; Obstruction of Flow

  BW RECEIVED 2 BOXES OF 32G X 4MM FROM THE VA WITH LOT NO. Z58K6. HE INJECTS 18 UNITS OF LANTUS 1X PER DAY WITH LANTUS SOLOSTAR PEN. HE STATES THAT THE PEN NEEDLE DOESN'T ALLOW A FULL INJECTION. IE: HE INJECTS 18 UNITS AND THE INJECTION STOPS AT 5 AND HE HAS TO SWITCH NEEDLES IN ORDER TO RECEIVE THE REST OF THE INJECTION. HE STATED THIS HAPPENS 1 OUT OF EVERY 5 PN'S AND SOMETIMES, THE PN JUST DOESN'T WORK AT ALL. MR. WENZEL DOES NOT PRIME HIS PNS ALL THE TIME BUT, HAS BEEN LATELY. HE DOES NOT REUSE PNS.

  Patient problems: No Information

  MAUDE report 9608123 ↗
• MalfunctionJan 20, 2020Partial Blockage; Obstruction of Flow; Partial Blockage; Obstruction of Flow

  LW RECEIVED 1 BOX OF 32G X 4MM FROM HUMANA WITH LOT NO. Z58M2. SHE INJECTS LANTUS 4X PER DAY WITH A LANTUS SOLOSTAR PEN. SHE STATES PN DOESN'T CORRESPOND WITH THE PEN. SHE SAID THE NEEDLES DO NOT GO INTO HER STOMACH. SHE STATED THAT THE INSULIN LITERALLY LEAKS OUT HER SKIN. SHE USED THE PRODUCT FOR A WEEK AND HAD AN ISSUE EVERY SINGLE TIME SO, SHE WENT TO THE PHARMACY AND BOUGHT THE BD BRAND THAT SHE WAS USED TO GETTING AND HASN'T HAD AN ISSUE SINCE.

  Patient problems: No Information

  MAUDE report 9608122 ↗
• 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 8674057 ↗
• MalfunctionApr 30, 2019Obstruction of Flow; Material Twisted/Bent; Obstruction of Flow; Material Twisted/Bent

  THESE PEN NEEDLES DON'T PENETRATE THE SKIN - THEY BEND. INSULIN IS NOT GOING IN - I'M LOSING A LOT OF INSULIN. I'M GOING THROUGH SEVERAL NEEDLES A DAY."

  Patient problems: No Information

  MAUDE report 8564347 ↗
• MalfunctionFeb 21, 2019Dull, Blunt; Dull, Blunt

  NEEDLES ARE VERY DULL.

  Patient problems: No Information

  MAUDE report 8357128 ↗
• MalfunctionFeb 12, 2019Infusion or Flow Problem; Material Twisted/Bent; Infusion or Flow Problem; Material Twisted/Bent

  PATIENT CALLING THAT PEN NEEDLES WILL NOT DISPENSE INSULIN REGULARLY AND THEY WILL BEND.

  Patient problems: No Information

  MAUDE report 8330389 ↗
• MalfunctionFeb 12, 2019Dull, Blunt; Insufficient Device Problem Information; Dull, Blunt; Insufficient Device Problem Information

  PHARMACIST WAS CONTACTED BY PATIENT. PATIENT SAID THE PEN NEEDLES WERE DIFFICULT TO PENETRATE THE SKIN AND ALSO EXPERIENCED LEAKING AT INJECTION SITE.

  Patient problems: No Information

  MAUDE report 8330283 ↗
• MalfunctionFeb 11, 2019Dull, Blunt; Dull, Blunt

  HAVE BEEN USING YOUR 32GX5/32 NEEDLES FOR MY DIABETES. THEY SAY THEY ARE COATED. THEY ARE THE HARDEST TO PIERCE AND SEEMS THEY ARE VERY HARD TO PUSH IN AFTER PIERCING.

  Patient problems: No Information

  MAUDE report 8324922 ↗
• MalfunctionFeb 11, 2019Dull, Blunt; Dull, Blunt

  HAVE BEEN USING YOUR 32GX5/32 NEEDLES FOR MY DIABETES. THEY SAY THEY ARE COATED. THEY ARE THE HARDEST TO PIERCE AND SEEMS THEY ARE VERY HARD TO PUSH IN AFTER PIERCING.

  Patient problems: No Information

  MAUDE report 8324884 ↗
• 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 8324835 ↗
• MalfunctionJan 21, 2019Component Missing; Component Missing

  PATIENT HAD ONE PEN NEEDLE THAT WAS MISSING THE NON-PATIENT END.

  Patient problems: No Information

  MAUDE report 8263545 ↗