MEDLINE SSN100235Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10193489031959), received between Dec 11, 2025 and Sep 30, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Decoupling; Detachment of Device or Device Component; Positioning Problem

  It was reported that "THE NEEDS TWIST OFF THE SYRINGE," "NEEDLE CAPS FALL OFF WHEN OPENING THE NEEDLE OUT OF THE PACKAGE," and "THE SAFETY CAP WILL NOT STAY IN OPEN POSITION."

  Patient problems: Needle Stick/Puncture

  MAUDE report 50944757 ↗
• MalfunctionSep 24, 2026Connection Problem

  It was reported that "needle popped off syringe and poked employee. another incident - needle popped off and needle stuck in baby."

  Patient problems: Foreign Body In Patient; Needle Stick/Puncture

  MAUDE report 50884574 ↗
• MalfunctionSep 24, 2026Obstruction of Flow

  It was reported that "one of the MAs was administering a vaccine and wasn¿t able to get the medicine to flow completely out of the needle. At a certain point the needle seemed to jam."

  Patient problems: Needle Stick/Puncture

  MAUDE report 50882447 ↗
• MalfunctionSep 23, 2026Detachment of Device or Device Component

  It was reported that "The customer has experienced a syringe with the cap falling off as it was placed in desk."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870158 ↗
• MalfunctionSep 23, 2026Activation Failure

  It was reported that "The safety needle did not close all the way."

  Patient problems: Needle Stick/Puncture

  MAUDE report 50869270 ↗
• MalfunctionSep 21, 2026Connection Problem; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842897 ↗
• MalfunctionSep 21, 2026Detachment of Device or Device Component

  It was reported that "Lab team confirms that safety closers fall off."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842543 ↗
• MalfunctionSep 17, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  It was reported that the cap falls off at random causing "clean" needle sticks and when safety cover is engaged, needle splashes blood.

  Patient problems: Needle Stick/Puncture

  MAUDE report 50802464 ↗
• MalfunctionSep 16, 2026Decoupling

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793824 ↗
• MalfunctionSep 16, 2026Dull, Blunt

  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 50793000 ↗
• MalfunctionSep 15, 2026Protective Measures Problem; Material Too Soft/Flexible

  Patient problems: Needle Stick/Puncture

  MAUDE report 50778242 ↗
• MalfunctionSep 14, 2026Blocked Connection

  It was reported that "needle popped off syringe and poked employee. another incident - needle popped off and needle stuck in baby."

  Patient problems: Needle Stick/Puncture

  MAUDE report 50760772 ↗
• MalfunctionSep 14, 2026Detachment of Device or Device Component; Material Integrity Problem

  It was reported that "the sharps cover falls off prior to engagement which could increase the amount of needle sticks."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754611 ↗
• MalfunctionSep 12, 2026Material Puncture/Hole; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50746761 ↗
• MalfunctionSep 12, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50746751 ↗
• MalfunctionSep 11, 2026Protective Measures Problem; Material Too Soft/Flexible

  It was reported that there have been 4 reports of needle sticks due to the needle not being sheathed when coming out of the package. The account is also stating the item is too flimsy and does not meet the standards of a safety locking mechanism.

  Patient problems: Needle Stick/Puncture

  MAUDE report 50735358 ↗
• InjuryDec 11, 2025Difficult to Open or Close; Physical Resistance/Sticking

  RN WAS USING NEW SAFETY NEEDLE (23G) WHILE ADMINISTERING COVID VACCINE. THE SAFETY NEEDLE DID NOT CLOSE ALL THE WAY AND THE RN WAS STUCK WHEN TRYING TO PLACE NEEDLE IN THE SHARPS CONTAINER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778532 ↗