DropSafe Safety Needle 25GRecalls & reported problems
Htl Strefa S A · The sterile Safety Needle is intended for use in the aspiration and injection of fluids for medical purpose. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 85907996099319), received between Jun 22, 2022 and Jul 12, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 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 16, 2026.
Most reported problems
Device problems
- Physical Resistance/Sticking3
- Fail-Safe Problem1
Patient problems
- Needle Stick/Puncture3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 12, 2023Physical Resistance/Sticking; Physical Resistance/Sticking
COMPLAINANT REPORTED THAT THE SAFETY MECHANISM FROM THE NEEDLE SUPPLIED WITH THE ANCILLARY KIT FAILED AND CAUSED A BLOOD BORNE PATHOGEN EXPOSURE. THE SAFETY MECHANISM WAS CLOSED, BUT THE NEEDLE WAS STICKING OUT OF THE SAFETY MECHANISM, AND WHEN THE CAREGIVER WENT TO DISPOSE OF IT IN THE SHARP CONTAINER, IT STUCK THEM.
Patient problems: Needle Stick/Puncture
MAUDE report 17312849 ↗MalfunctionNov 11, 2022Physical Resistance/Sticking; Physical Resistance/Sticking
CUSTOMER REPORTED AN ISSUE WITH THE STREFA PRODUCT SUPPLIED IN THE KIT, INDICATING THAT THE SAFETY DOESN'T ALWAYS LATCH RIGHT AWAY. CUSTOMER STATED THAT IT TAKES MORE PRESSURE TO GET THE SAFETY TO ENGAGE. THE CUSTOMER PROVIDED MANUFACTURER PRODUCT # 6059 AND LOT # SN25250018 AS ADDITIONAL PRODUCT IDENTIFICATION INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15781069 ↗MalfunctionJul 1, 2022Fail-Safe Problem; Fail-Safe Problem
THE SAFETY NEEDLE DOES NOT CLOSE PROPERLY OR ALL THE WAY SO IT IS A HAZARD FOR OUR EMPLOYEES. WE DID HAVE A RECENT NEEDLE STICK IN THE CLINIC BUT MEDICAL ATTN WAS NOT REQUIRED.
Patient problems: Needle Stick/Puncture
MAUDE report 14883790 ↗MalfunctionJun 22, 2022Physical Resistance/Sticking; Physical Resistance/Sticking
CUSTOMER REPORTED THAT THE SAFETY NEEDLE PROVIDED IN AN ANCILLARY CONVENIENCE KIT DOES NOT CLOSE PROPERLY OR CLOSE COMPLETELY, AND IS THEREFORE A HAZARD FOR THE EMPLOYEES. A USER RECENTLY EXPERIENCED A NEEDLE STICK INJURY IN THE CLINIC. USERS HAVE INDICATED THAT THE TOP CLICK IS NOT HOLDING THE NEEDLE DOWN, AND THAT IT REQUIRES 2 CLICKS TO HOLD THE NEEDLE DOWN.
Patient problems: Needle Stick/Puncture
MAUDE report 14777914 ↗
Other Syringe, Antistick devices
- BD Integra 305270Becton, Dickinson And Company · SYRINGE, ANTISTICK261 reports
- BD Integra 305271Becton, Dickinson And Company · SYRINGE, ANTISTICK106 reports
- BD Integra 305269Becton, Dickinson And Company · SYRINGE, ANTISTICK85 reports
- BD Luer-Lok, BD SafetyGlide 305924Becton, Dickinson And Company · SYRINGE, ANTISTICK1 recall28 reports
- BD Integra 305272Becton, Dickinson And Company · SYRINGE, ANTISTICK71 reports
- BD SafetyGlide 305945Becton, Dickinson And Company · SYRINGE, ANTISTICK63 reports
- BD SafetyGlide 305950Becton, Dickinson And Company · SYRINGE, ANTISTICK61 reports
- Medline SYRS103225Medline Industries, Inc. · SYRINGE, ANTISTICK1 recall0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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