droplet insulin syringes 1ml, 31 x 6mmRecalls & reported problems
Htl Strefa S A · droplet insulin syringes with fixed needle is a sterile single use syringe for the injection of U-100 insulin only. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05907996095605), received between May 16, 2025 and May 16, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Decoupling” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Decoupling1
Patient problems
- Needle Stick/Puncture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 2025Decoupling; Decoupling
CUSTOMER REPORTED: CUSTOMER STATED HE'S HAVING PROBLEMS WITH THE CAPS ON HIS SYRINGES FALLING OFF, EXPOSING THE NEEDLE. HE HAS ACCIDENTALLY PRICKED HIS HANDS WITH NEEDLES THAT WERE EXPOSED BY CAPS THAT WERE LOOSE AND HAD FALLEN OFF. CUSTOMER HAS NOT HAD ANY SERIOUS INJURY OUTSIDE OF THE FINGER PRICKS FROM LOOSE CAPS. HE HAS BEEN ABLE TO COMPLETE HIS INJECTIONS, BUT HE'S CONCERNED ABOUT THE NUMBER OF LOOSE CAPS AND IN THE BOX.
Patient problems: Needle Stick/Puncture
MAUDE report 22035410 ↗
Other Syringe, Piston devices
- BD Luer-Lok 309657Becton, Dickinson And Company · Syringe, piston1,266 reports
- BD Luer-Lok 309653Becton, Dickinson And Company · Syringe, piston948 reports
- BD Luer-Lok 309628Becton, Dickinson And Company · Syringe, piston862 reports
- N/A 302995Becton, Dickinson And Company · Syringe, piston1 recall537 reports
- BD Plastipak Syringe 300865Becton, Dickinson And Company · Syringe, piston515 reports
- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
- N/A 302832Becton, Dickinson And Company · Syringe, piston424 reports
- BD Ultra-Fine 328468Becton, Dickinson and Company Inc · Syringe, piston323 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.
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