MEDLINE SSN100255Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 10193489031980), received between Apr 14, 2024 and Sep 30, 2026 — classified as 3 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (15 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 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952372 ↗
• MalfunctionSep 30, 2026Loose or Intermittent Connection; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952343 ↗
• MalfunctionSep 30, 2026Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951024 ↗
• MalfunctionSep 30, 2026Disconnection; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950807 ↗
• MalfunctionSep 30, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949051 ↗
• MalfunctionSep 30, 2026Disconnection

  It was reported that "Multiple times when administering a vaccine and the needle would come unscrewed from the syringe/immunization and stay in the patients arm or leg, and the syringe in their hand. Also, another time the immunization liquid came out when pushing the plunger through the syringe."

  Patient problems: Foreign Body In Patient

  MAUDE report 50945379 ↗
• MalfunctionSep 29, 2026Decoupling

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936743 ↗
• MalfunctionSep 29, 2026Detachment of Device or Device Component

  It was reported that CLINICAL STAFF WAS HAVING ISSUES ON THE CAPS NOT STAYING SECURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934028 ↗
• MalfunctionSep 29, 2026Disconnection; Fluid/Blood Leak

  It was reported that "our current needles that we are using for prefilled vaccines are popping off the syringe, leaking and just not working well."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932388 ↗
• MalfunctionSep 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925983 ↗
• MalfunctionSep 28, 2026Disconnection

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50923556 ↗
• MalfunctionSep 25, 2026Loose or Intermittent Connection; Difficult to Open or Close

  It was reported that "the clear plastic cap for the needle (see below image) is very loose when opening the package and has a potential to cause needle sticks when assembling the syringe."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898841 ↗
• MalfunctionSep 25, 2026Packaging Problem

  It was reported that "The safety came off an stuck the nurse."

  Patient problems: Needle Stick/Puncture

  MAUDE report 50897192 ↗
• MalfunctionSep 24, 2026Separation Failure; Material Twisted/Bent

  It was reported that "The nurses went to engage the safety and the needle bent and they got a stick from the needle." "They also mentioned that the safety part isn't coming off on some of these."

  Patient problems: Needle Stick/Puncture

  MAUDE report 50885163 ↗
• MalfunctionSep 24, 2026Fluid/Blood Leak; Material Twisted/Bent

  It was reported that items recieved were bent & leaked. were unable to be used.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884049 ↗
• MalfunctionSep 24, 2026Disconnection

  It was reported that "Our clinic had a flu clinic this weekend and had many issues with this needle backing itself off of the vaccines."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882182 ↗
• MalfunctionSep 24, 2026Disconnection; Fluid/Blood Leak

  It was reported that "the liquid shot through the hub instead of the needle."

  Patient problems: Chemical Exposure; Foreign Body In Patient

  MAUDE report 50882164 ↗
• MalfunctionSep 23, 2026Disconnection; Dull, Blunt; Detachment of Device or Device Component

  It was reported that "Today I had to go through 4 before I had one that would luerlock onto my vaccine. The caps fly off, we have had 2 instances where the needle itself came off and thankfully we prevented a needle stick injury. Many of the needles "drag" into the skin as if the needle is not sharp."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873052 ↗
• MalfunctionSep 23, 2026Disconnection; Loose or Intermittent Connection

  It was reported that the nurses have been complaining about the needle on the syringe coming off, not staying on while giving vaccine, they stated it is sliding and they have to hold the actual needle when injecting vaccine into arm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871133 ↗
• MalfunctionSep 23, 2026Detachment of Device or Device Component

  It was reported that "Caps come off the needle very easily."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870994 ↗
• MalfunctionSep 23, 2026Decoupling

  It was reported that they are having issues with the needle coming unattached.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870581 ↗
• MalfunctionSep 23, 2026Detachment of Device or Device Component

  It was reported that "several complaints that the plastic cover does not stay on the needle, so when opening the package it falls off and someone could easily get stuck. Same goes for if they are taking the needle from med room to the patient¿s room."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868326 ↗
• MalfunctionSep 21, 2026Disconnection

  It was reported that "when twisting in the needle, it would unseat the connector. The barrel length seems to be the issue as the covidien is shorter and does not do this."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50844874 ↗
• MalfunctionSep 21, 2026Blocked Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842581 ↗
• MalfunctionSep 19, 2026Dull, Blunt

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831826 ↗