DropSafe, safety pen needles 31G x 6mmRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05907996091584), received between Nov 4, 2019 and May 20, 2026 — classified as 5 injuries, 1 malfunction.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2026Material Twisted/Bent; Fail-Safe Did Not Operate

  ON 04/22/2026 HTL-STREFA INC. RECEIVED AN EMAIL NOTIFICATION. CUSTOMER STATED: THE NEEDLE CAME OUT OF THE SIDE AND STUCK A NURSE. WE TESTED MULTIPLE ONES AND IT HAPPENS WITH THEM ALL. SUPPOSED TO BE A SAFETY NEEDLE. PHOTO HAS BEEN ATTACHED TO THE NOTIFICATION. HTL-STREFA MADE ATTEMPT TO OBTAIN ADDITIONAL INFORMATION TO THE EVENT CIRCUMSTANCES. WITHOUT RESULTS. ON 2026-05-15 SAMPLE UNDER COMPLAINT HAS BEEN RETURNED FOR FURTHER ANALYSIS.

  Patient problems: Needle Stick/Puncture

  MAUDE report 25228051 ↗
• InjuryApr 14, 2026Material Twisted/Bent; Fail-Safe Did Not Operate

  ON 04/01/2026 HTL-STREFA INC. RECEIVED AN EMAIL COMPLAINT NOTIFICATION. CUSTOMER REPORTED A NEEDLESTICK AT THE FACILITY. AFTER YOU INJECT THE INSULIN, THE NEEDLE IS RETRACTING BACK BUT STICKS OUT THE SIDE AND CAUSED A NEEDLESTICK. PHOTO HAS BEEN ATTACHED TO THE NOTIFICATION. ON THE PROVIDED PHOTO WE CAN SEE BENT NEEDLE FROM THE USER END. THE NEEDLE IS EXPOSED FROM SAFETY PEN NEEDLE. HTL-STREFA MADE ATTEMPT TO OBTAIN ADDITIONAL INFORMATION TO THE EVENT CIRCUMSTANCES.

  Patient problems: Needle Stick/Puncture

  MAUDE report 24870589 ↗
• InjuryApr 14, 2026Material Twisted/Bent; Fail-Safe Did Not Operate

  ON 03/23/2026 HTL-STREFA INC. RECEIVED AN EMAIL COMPLAINT NOTIFICATION. CUSTOMER STATED: THE NEEDLE CAME OUT OF THE SIDE AND STUCK A NURSE. WE TESTED MULTIPLE ONES AND IT HAPPENS WITH THEM ALL. SUPPOSED TO BE A SAFETY NEEDLE.CUSTOMER WAS CALLED SEVERAL TIMES WITH NO ANSWER AND NO OPTION FOR LEAVING A CALL BACK MESSAGE. EMAIL WAS SENT FOR ADDITIONAL INFORMATION.ON 2026-04-22 SAMPLE UNDER COMPLAINT HAS BEEN RETURNED FOR FURTHER ANALYSIS.

  Patient problems: Needle Stick/Puncture

  MAUDE report 24870298 ↗
• MalfunctionMar 21, 2023Material Fragmentation; Material Fragmentation

  JW SENT THE INITIAL EMAIL TO HTL INC. SHE WRITES, "RECENTLY, WE HAVE HAD AN ISSUE WITH AN ACCIDENTAL NEEDLE STICK DUE TO A FAULTY LOT OF NEEDLES WE WERE SENT. PLEASE SEE THE ATTACHED PHOTOS OF THE ISSUE AND ADVISE HOW THIS ISSUE CAN BE PREVENTED IN THE FUTURE." JW FORWARDED INFORMATION FROM THE CLINICAL TEAM LEADER, JK, AT THE FACILITY WHERE THE INCIDENT OCCURS THE FACILITY IS OCONTO HOSPITAL CLINIC. THE TEAM LEADER WRITES, "HELLO TEAMS, SITUATION: A NEEDLESTICK OCCURRED RELATED TO A FAULTY INSULIN PEN NEEDLE- DROPSAFE BRAND LOT C68H4 (SEE PICTURES) BACKGROUND: THE NEEDLE INSERTED INTO THE PEN AT AN ANGLE AND CAUSED IT TO GET LODGED IN THE PEN EVEN AFTER THE CAP WAS REMOVED. THE NURSE ADMINISTERING THE NEXT DOSE OF INSULIN WENT TO SCRUB THE TOP OF THE INSULIN PEN AND GOT POKED BY THE FAULTY, RETAINED NEEDLE. ASSESSMENT: BHOH'S SUPPLY CHAIN SWITCHED TO THESE INSULIN PEN NEEDLES A COUPLE OF MONTHS AGO. REVIEW WHAT PRODUCTS YOU HAVE IN YOUR AREA. RECOMMENDATION: ADVISE NURSES TO WATCH FOR RETAINED NEEDLES AS THEY REMOVE THE INSULIN PEN NEEDLES AND BEFORE THEY SCRUB THE CAP TO PUT A NEW ONE ON."

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16581175 ↗
• InjuryNov 4, 2019Material Twisted/Bent; Material Twisted/Bent

  'I WAS JUST MADE AWARE OF A NEEDLE STICK THAT OCCURRED IN OUR (B)(6) FACILITY USING ONE OF THE DROP SAFE PEN NEEDLES THAT CAME OUT OF THE SIDE OF THE DEVICE. ADDITIONAL DETAILS - HERE IS THE INFO REGARDING THE NEEDLE STICK:. THE NURSE - SHE WAS ATTEMPTING TO REMOVE THE USED NEEDLE AT THE END OF THE INSULIN PEN, THE NEEDLE WAS BENT THROUGH ONE OF THE OPENING ON THE DROP SAFE PEN NEEDLES AND IT CAME OUT OF THE SIDE OF THE DEVICE. SHE QUICKLY REPORTED AND SHOWED THE SUPERVISOR WHAT HAD HAPPENED. WE SENT HER TO (B)(6) LAB FOR BLOOD DRAW AND THE FIRST ROUND OF RESULTS WERE NEGATIVE. SHE WILL FOLLOW THE SERIAL LAB TESTING PROTOCOL UNTIL COMPLETED'.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9271437 ↗
• InjuryNov 4, 2019Material Deformation; Material Deformation

  'I WAS JUST MADE AWARE OF A NEEDLE STICK THAT OCCURRED IN OUR (B)(6) FACILITY USING ONE OF THE DROP SAFE PEN NEEDLES THAT CAME OUT OF THE SIDE OF THE DEVICE. ADDITIONAL DETAILS - HERE IS THE INFO REGARDING THE NEEDLE STICK:. THE NURSE - SHE WAS ATTEMPTING TO REMOVE THE USED NEEDLE AT THE END OF THE INSULIN PEN, THE NEEDLE WAS BENT THROUGH ONE OF THE OPENING ON THE DROP SAFE PEN NEEDLES AND IT CAME OUT OF THE SIDE OF THE DEVICE. SHE QUICKLY REPORTED AND SHOWED THE SUPERVISOR WHAT HAD HAPPENED. WE SENT HER TO (B)(6) LAB FOR BLOOD DRAW AND THE FIRST ROUND OF RESULTS WERE NEGATIVE. SHE WILL FOLLOW THE SERIAL LAB TESTING PROTOCOL UNTIL COMPLETED'.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9271407 ↗