MEDLINE SSN100227Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10193489031942), received between Jun 5, 2024 and Sep 30, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951489 ↗
• MalfunctionSep 30, 2026Crack; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950955 ↗
• MalfunctionSep 30, 2026Connection Problem; Detachment of Device or Device Component

  It was reported that "the clear plastic cap instantly falls off when you remove it from the package. It also does not lock on when you try to replace it. In addition the black luer lock does not lock onto the syringe well. It has two tini threads to hold it onto the syringe vs a full ring that our previous needles have."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947766 ↗
• MalfunctionSep 30, 2026Connection Problem; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947694 ↗
• MalfunctionSep 29, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934156 ↗
• MalfunctionSep 24, 2026Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889263 ↗
• MalfunctionSep 24, 2026Connection Problem; Material Twisted/Bent; Unintended Movement

  It was reported that "When twisting the needle onto the syringe, it does not lock properly; it spins and does not tighten down. Needles have fallen out of syringe and stay in the patient's arm."

  Patient problems: Foreign Body In Patient; Unspecified Tissue Injury

  MAUDE report 50882619 ↗
• MalfunctionSep 23, 2026Connection Problem

  It was reported that ¿the clear plastic cap instantly falls off when you remove it from the package¿ and ¿the black luer lock does not lock onto the syringe well.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870823 ↗
• MalfunctionSep 23, 2026Detachment of Device or Device Component; Unintended Movement

  It was reported that the item has the same type of flip safety feature that falls easily and prevents provider from giving the injection until it can be moved out of the way; safety cover is loose and flips, nearly covering the needle.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868833 ↗
• MalfunctionSep 21, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849257 ↗
• MalfunctionSep 21, 2026Connection Problem; Detachment of Device or Device Component

  It was reported that "the clear plastic cap instantly falls off when you remove it from the package," "It also does not lock on when you try to replace it," and "the black luer lock does not lock onto the syringe well."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843116 ↗
• MalfunctionSep 18, 2026Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50823313 ↗
• MalfunctionSep 17, 2026Loose or Intermittent Connection; Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809251 ↗
• MalfunctionSep 17, 2026Packaging Problem

  It was reported that the cap falls off while they are attaching the needle to the syringe. We have also heard the safety is difficult to use and does not always snap on securely.

  Patient problems: Needle Stick/Puncture

  MAUDE report 50808012 ↗
• MalfunctionSep 17, 2026Failure to Align; Detachment of Device or Device Component; Incomplete or Inadequate Connection

  It was reported that the luer lock is inconsistent when engaging with the syringe, sometimes not engaging at all and sometimes engaging only half-way requiring the nurse to get a new needle and start over to ensure that there would be no leakage of medication; the clear plastic needle cover is not snapped on the needle and as they pull the paper apart, the needle is not covered as it comes out of the sterile wrapper- a few clean needle sticks have occurred ¿ the cover is loose in the wrapper; the safety that should be able to be easily engaged after the injection but it is not aligned properly resulting in increased risk of a dirty needle stick.

  Patient problems: Needle Stick/Puncture

  MAUDE report 50807873 ↗
• MalfunctionSep 17, 2026Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805275 ↗
• MalfunctionSep 17, 2026Packaging Problem

  It was reported that "The clear cap covering the needle comes off without pulling it off. While Dr P was injecting the gray safety cover came off so she was not able to safely cap the needle."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50804663 ↗
• MalfunctionSep 16, 2026Connection Problem; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50789428 ↗
• MalfunctionSep 15, 2026Connection Problem; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50780882 ↗
• MalfunctionSep 15, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779952 ↗
• MalfunctionSep 15, 2026Material Too Soft/Flexible

  It was reported that "the doctors/anesthesia have complained that they are very flimsy."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50772654 ↗
• MalfunctionSep 14, 2026Connection Problem

  It was reported that "the clear plastic cap instantly falls off when you remove it from the package," "It also does not lock on when you try to replace it," and "the black luer lock does not lock onto the syringe well."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50752674 ↗
• MalfunctionSep 14, 2026Fitting Problem; Detachment of Device or Device Component

  It was reported that "The safety cap tends to fall off when taking the needle out of the packages and the needle has had difficulty attaching to syringes."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50752668 ↗
• MalfunctionSep 13, 2026Packaging Problem

  Patient problems: Needle Stick/Puncture

  MAUDE report 50747782 ↗
• MalfunctionSep 9, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50698841 ↗