CAINA 25501Recalls & reported problems
Jiangsu Caina Medical Co.,Ltd · Safety needle 25Gx1.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 maintenance package · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 06971564465021), received between Oct 20, 2023 and May 4, 2024 — classified as 3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Tissue Injury1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
CUSTOMER IS HAVING ISSUES WITH THE LUER-LOCKS ON THE NEEDLES. THEY HAVE HAD CLINICIANS GETTING STUCK AND NEEDLES COMING IN PATIENTS ARMS. CUSTOMER IS VERY UPSET THAT THIS HAS BEEN HAPPENING OVER THE LAST MONTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19244509 ↗MalfunctionApr 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT SAFETY NEEDLE DETACHED FROM SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102864 ↗MalfunctionOct 20, 2023
SEVERAL EVENTS WITH MEDLINE INSULIN SYRINGE, MEDLINE SURE-SNAP SAFETY NEEDLE AND CAINA SAFETY NEEDLE. WHEN TWISTING THE NEEDLE ONTO THE SYRINGE, IT DOES NOT LOCK PROPERLY; IT SPINS AND DOES NOT TIGHTEN DOWN. NEEDLES ARE BENDING WHEN TRYING TO PULL UP MEDICATION AS WELL AS WHEN PUT INTO PATIENT'S ARM. NEEDLES HAVE FALLEN OUT OF SYRINGE AND STAY IN THE PATIENT'S ARM. THE SAFETY ON THE NEEDLE CONTINUES TO MOVE LOOSELY AND WILL FLOP DOWN AND NOT STAY STATIONARY. SAFETY ON THE NEEDLE ALSO DOES NOT ALWAYS CLOSE CORRECTLY. SOME OF THESE EVENTS HAVE CAUSED EMPLOYEE INJURY. LOT NUMBERS ATTACHED ARE EXAMPLES, BUT NOT INCLUSIVE. MANUFACTURER RESPONSE FOR SYRINGE, PISTON, MEDLINE (PER SITE REPORTER). UNKNOWN. MANUFACTURER RESPONSE FOR NEEDLE, HYPODERMIC, SINGLE LUMEN, CAINA (PER SITE REPORTER). UNKNOWN.
Patient problems: Unspecified Tissue Injury
MAUDE report 17974781 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.