Medline SSN100257Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10193489031997), received between Mar 13, 2024 and Sep 30, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949703 ↗
• MalfunctionSep 28, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921975 ↗
• MalfunctionSep 24, 2026Entrapment of Device; Detachment of Device or Device Component

  It was reported that "when injecting into patients arms it is tearing the skin. Another instance is the needle got stock in a patient arm as well I was told".

  Patient problems: Foreign Body In Patient; Skin Tears

  MAUDE report 50885134 ↗
• MalfunctionSep 24, 2026Obstruction of Flow

  This VMSR report summarizes approximately 10 malfunction events that occurred during Q3 2025 (July 1, 2025 through September 30, 2025). The account reported that injections were interrupted because the medication stopped dispensing mid-injection when using the affected product. The customer indicated that the issue was observed across four different lots and had occurred with approximately ten patients. The product was reportedly used with Kenalog and lidocaine administered via a 3 mL syringe. The reported malfunction resulted in incomplete delivery of medication during injection procedures. Samples were returned for evaluation under a related complaint, and additional complaint records were opened to document the affected lots. No serious injuries were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882107 ↗
• MalfunctionSep 18, 2026Disconnection; Fluid/Blood Leak

  It was reported that "It was happening with our pre-drawn influenza vaccines and was leaking from the luer connector" and "One needle detached and was left in a patient's arm."

  Patient problems: Foreign Body In Patient

  MAUDE report 50817818 ↗
• MalfunctionSep 15, 2026Incomplete or Inadequate Connection

  It was reported that "The Luer Lok function on these needles does not work 100% of the time" and "This has led to the needle remaining in our patients after injecting medication because the needle device un-screws from the syringe."

  Patient problems: Foreign Body In Patient

  MAUDE report 50773189 ↗
• MalfunctionSep 13, 2026Disconnection

  Patient problems: Needle Stick/Puncture

  MAUDE report 50746954 ↗
• MalfunctionSep 9, 2026Loose or Intermittent Connection; Material Twisted/Bent

  It was reported that "The needles bend easily and the orange safety piece is \"loose.\" It does not stay in place." It was also reported that "When the needle is attached to a syringe and the surgeon goes to inject local, the safety piece falls forward making in possible to advance the needle without putting your finger by the needle to pull/hold back the safety piece."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50694834 ↗
• MalfunctionSep 9, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50690438 ↗
• MalfunctionSep 8, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50677347 ↗
• InjuryOct 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE FACILITY ON 9/30, "I WAS TRYING TO ADMINISTER A FLULAVAL VACCINE. I SECURED THE MEDLINE 25G, 1.5" SURE-SNAP SAFETY NEEDLE TO THE PRE-FILLED SYRINGE, AS IS TYPICAL FOR VACCINE ADMINISTRATION, AND WENT TO ADMINISTER THE VACCINE. AS I PRESSED IN THE PLUNGER OF THE SYRINGE, THE NEEDLE DETACHED FROM THE SYRINGE AND THE VACCINE WASTED OUTSIDE OF THE PATIENT'S SHOULDER.".

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20569756 ↗
• MalfunctionJun 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE NEEDLE COMES OUT OF THE SYRINGE WHEN PERFORMING INJECTIONS AND STAYED IN THE PATIENT SKIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19465086 ↗
• MalfunctionMar 13, 2024Connection Problem; Connection Problem

  NEEDLE CAME OFF SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18893849 ↗