droplet® pen needles 31Gx8mmRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00857273002237), received between Oct 15, 2025 and Jun 1, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 2026Break; Fluid/Blood Leak; Material Fragmentation; Material Twisted/Bent

  ON 05/22/2026 HTL-STREFA INC. RECEIVED A PHONE CALL COMPLAINT. CUSTOMER STATED SEVERAL PEN NEEDLE HAVE BENT AND BROKEN OFF IN THE SKIN DURING INJECTIONS. HE WAS ABLE TO REMOVE THE BROKEN NEEDLES USING TWEEZERS. HE ALSO MENTIONED INSULIN SPILLING OUT OF THE PEN NEEDLE DURING INJECTION ATTEMPT RESULTING IN A SPIKE OF HIS SUGAR LEVELS. THE CUSTOMER REPORTED A SUGAR SPIKE OF MORE THAN 300. THE CUSTOMER DID SEEK MEDICAL ATTENTION FOR THE SPIKE OR BROKEN NEEDLES. HE USES LANTUS SOLOSTAR. THE CUSTOMER CONFIRMED ROTATING INJECTION SITES AND FOLLOWS THE IFU. WE ARE PROVIDING REPLACEMENT SAMPLES AND THE CUSTOMER AGREED TO SUBMIT SAMPLES FOR INVESTIGATION ANALYSIS. ADDITIONAL INFORMATION: THE CUSTOMER DID NOT SEEK MEDICAL ATTENTION AND WAS ABLE TO REMOVE THE BROKEN NEEDLE USING TWEEZERS. YES, HIS SUGAR LEVELS ARE NORMAL NOW AND HE IS IN GOOD CONDITION. SAMPLE UNDER COMPLAINT HAS NOT BEEN RETURNED TO HTL-STREFA S.A. FOR FURTHER ANALYSIS.

  Patient problems: Foreign Body In Patient; Hyperglycemia

  MAUDE report 25346162 ↗
• MalfunctionJan 8, 2026Material Twisted/Bent

  (B)(6) 2025, HTL-STREFA RECEIVED A PHONE CALL COMPLAINT. CUSTOMER STATED EXPERIENCE SEVERAL PEN NEEDLES HAVE BENT ON CONTACT. CUSTOMER INJECTS 3 TIMES PER DAY. CUSTOMER HAS REPORTED MIS DOSING WITH OF HIS INJECTIONS DISCOVERED THROUGH A MONITORING DEVICE. HE WAS ABLE TO ACHIEVE HIS REQUIRED DOSE USING A DIFFERENT PEN NEEDLE AND DID NOT SEEK MEDICAL ATTENTION. CUSTOMER CONFIRMED HE FOLLOWS THE IFU AND ROTATES INJECTION SITES. CUSTOMER IS CONCERNED THE PEN NEEDLES ARE NOT MEETING SPECIFICATION AND WOULD LIKE THE MANUFACTURER TO INVESTIGATION. HE USES SOLIQUA PEN INJECTOR. WE ARE PROVIDING REPLACEMENT SAMPLES, AND WE ARE NOT CERTAIN IF THE CUSTOMER WILL HAVE AVAILABLE SAMPLES FOR INVESTIGATION ANALYSIS.ADDITIONAL QUESTION ABOUT BLOOD SUGAR LEVEL HAS BEEN SENT TO THE PATIENT. DESPITE MULTIPLE ATTEMPTS, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED DUE TO THE LACK OF CONTACT WITH THE USER.ON 2026-01-16 SAMPLE UNDER COMPLAINT HAS BEEN RETURNED FOR FURTHER ANALYSIS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003242 ↗
• MalfunctionDec 16, 2025Break; Material Fragmentation; Dull, Blunt; Break; Material Fragmentation; Dull, Blunt

  ON 12/10/2025 (B)(6). RECEIVED A PHONE CALL COMPLAINT PEN NEEDLES ARE FAILING TO PENETRATE THE SKIN. THE PEN NEEDLES WILL NOT PENETRATE THE SKIN WITHOUT EXCESSIVE FORCE. HE DESCRIBED THE PEN NEEDLES AS DULL. A PEN NEEDLE BROKE OFF INTO HIS SKIN, FORTUNATELY ENOUGH OF THE PEN NEEDLE WAS STICKING OUT AND HE WAS ABLE TO REMOVE IT WITH HIS FINGERS. HE DOES NOT FEEL COMFORTABLE USING THE PEN NEEDLES HE HAS CURRENTLY. HE USES LANTUS SOLOSTAR FOR HIS PEN INJECTIONS. HE HAS USED DROPLET PEN NEEDLES FOR 2 OR 3 YEARS AND CONFIRMED HE FOLLOWS THE IFU AND ROTATES INJECTION SITES. HE SUFFERED MIS DOSING BUT WAS ABLE TO ACHIEVE HIS REQUIRED DOSE USING A MONITORING DEVICE. HE DID NOT SUFFER ANY OTHER HEALTH CONSEQUENCE AND DID NOT SEEK ANY MEDICAL ATTENTION. WE ARE PROVIDING REPLACEMENT SAMPLES, AND WE EXPECT TO RECEIVE REPLACEMENT SAMPLES FOR INVESTIGATION ANALYSIS. SAMPLE UNDER COMPLAINT HAS BEEN NOT RETURNED OF FURTHER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816091 ↗
• MalfunctionDec 16, 2025Break; Material Fragmentation; Material Twisted/Bent; Break; Material Fragmentation; Material Twisted/Bent

  ON 12/10/2025 HTL-STREFA INC. RECEIVED A PHONE CALL COMPLAINT. CUSTOMER STATED HIS PEN NEEDLES ARE BENDING ON CONTACT WITH THE SKIN. HE ALSO SAID A PEN NEEDLE BROKE OFF INTO HIS SKIN AND HE HAD TO REMOVE IT USING TWEEZERS. HE USES HUMALOG, LANTUS, AND OZEMPIC PEN INJECTORS. HE ALSO REPORTED HAVING 5 TO 8 PEN NEEDLE THAT DID NOT HAVE A NEEDLE PRESENT. HE DID NOT SUFFER ANY MIS DOSING OR HEALTH CONSEQUENCES, ONLY THE NEEDLE THAT BROKE OFF THAT HE REMOVED. CUSTOMER CONFIRMED HE FOLLOWS THE IFU AND ROTATES INJECTION SITES. WE ARE PROVIDING REPLACEMENT PRODUCT, AND HE WAS NOT ABLE TO CONFIRM IF SAMPLES FOR INVESTIGATION ANALYSIS WOULD BE AVAILABLE. SAMPLE UNDER COMPLAINT HAS BEEN NOT RETURNED OF FURTHER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815280 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Material Twisted/Bent; Fluid/Blood Leak; Material Twisted/Bent

  ON (B)(6) 2025 HTL-STREFA INC. RECEIVED A PHONE CALL COMPLAINT. CUSTOMER STATED SEVERAL PEN NEEDLES BENDS ON CONTACT WITH THE SKIN DURING INJECTION ATTEMPTS. CUSTOMER STATED SHE RECENTLY SWITCHED TO DROPLET FROM ANONTHER BRAND. SHE STATED SUFFERING A SPIKE IN HER SUGAR LEVELS AFTER PEN NEEDLE BENT DURING HER INJECTION ATTEMPT. SHE CONFIRMED SEEING SOME OF THE INSULIN ON THE SKIN FOLLOWING THE ATTEMPT. SHE DID NOT SUFFER ANY OTHER HEALTH CONSEQUENCE AND DID NOT REQUIRE HOSPITAL VISIT OR OTHER HEALTH CARE SERVICES. SHE USES BASAGLAR FOR HER INJECTIONS. SHE CONFIRMED FOLLOWING THE IFU AND ROTATES INJECTIONS SITES. WE ARE PROVIDING REPLACEMENT SAMPLES, AND SHE AGREED TO SUBMIT SAMPLES FOR INVESTIGATION ANALYSIS. HTL-STREFA S.A. MADE AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION TO THE EVENT CIRCUMSTANCES - WITHOUT RESULTS. NO SAMPLE WAS RETURNED TO HTL-STREFA FOR FURTHER EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 23298148 ↗