CAINA 25G*5/8-01Recalls & reported problems
Jiangsu Caina Medical Co.,Ltd · Safety needle 25G*5/8.The Safety Needle is intended for use with a luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.The safety needle contained in a sterility · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06971564465106), received between Apr 14, 2024 and Apr 14, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE SAFETY NEEDLE CANNOT BE FIXED TO THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102875 ↗MalfunctionApr 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE SAFETY SHEATH DOESN'T STAY IN PLACE VERY WELL AND SOMETIMES SLIPS AND EVEN COME OFF TOGETHER, CAUSING SEVERAL OF MY NURSES TO GET NEEDLES STUCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102863 ↗
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- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
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- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 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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