MEDLINE SSN100302Recalls & reported problems
Medline Industries, Inc. · NEEDLE,HYPODERM,SAFETY, 30GX0.5 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10193489032031), received between Sep 12, 2026 and Sep 24, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component2
- Loose or Intermittent Connection2
- Material Twisted/Bent2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Needle Stick/Puncture2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Detachment of Device or Device Component
It was reported that "SAFETY IS TOO BULKY AND THE CAP COVERING THE NEEDLE IS FALLING OFF NOT SAFE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886503 ↗MalfunctionSep 24, 2026Break; Material Twisted/Bent
It was reported that "The needles are bending/breaking."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884966 ↗MalfunctionSep 17, 2026Break; Material Twisted/Bent
It was reported that "The needles are bending/breaking."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804161 ↗MalfunctionSep 12, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746648 ↗MalfunctionSep 12, 2026Loose or Intermittent Connection
Patient problems: Needle Stick/Puncture
MAUDE report 50746621 ↗MalfunctionSep 12, 2026Detachment of Device or Device Component
Patient problems: Needle Stick/Puncture
MAUDE report 50746273 ↗
Other Syringe, piston devices
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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