Magellan 8881833510 (UDI 10192253024746)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10192253024746), received between Apr 21, 2022 and Nov 22, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Problem” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2023Break; Break

  THE CUSTOMER REPORTED THE DEVICES ARE FAULTY AND KEPT BREAKING ON THE SKIN.ADDITIONAL INFORMATION RECEIVED STATED THE NEEDLE ITSELF WAS BREAKING. THIS HAPPENED 3 TO 4 TIMES SO THEY STOPPED USING IT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18191838 ↗
• MalfunctionNov 8, 2023Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY ECRI, AN ANONYMOUS ECRI MEMBER REPORTED THAT THERE WAS STAFF MEMBER NEEDLE STICK INJURY WITH A USED NEEDLE DUE TO THE SAFETY DOES NOT ENGAGE ALL THE WAY, SO THE TIP OF THE NEEDLE IS STILL EXPOSED. IT WILL CLICK MAKING YOU THINK IT'S LOCKED AND FULLY OVER THE NEEDLE WHEN IT ISN'T. IT IS ALSO EXTREMELY FLIMSY. THE NEEDLE FEELS AS IF THE SAFETY IS FULLY ENGAGED BUT A SMALL PART OF THE NEEDLE REMAINS UNSHEATHED. THEY ALSO NOTICED IF THE SAFETY IS PUSHED FURTHER TO ATTEMPT TO ENGAGE MORE, THE NEEDLE BEGINS TO BEND. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023 STATED THAT NO FIRST AID INTERVENTIONS NEEDED, HAND WASH ONLY. LABS WERE ORDERED. BLOOD/BODY FLUID EXPOSURE (BBFE PROTOCOL) INCLUDED RAPID HIV-1, HIV-2, HEP B AND HEP C AND ALL RESULTED NEGATIVE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 18097439 ↗
• MalfunctionNov 8, 2023Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY ECRI, AN ANONYMOUS ECRI MEMBER REPORTED THAT THE SAFETY DOESN'T ENGAGE ALL THE WAY, SO THE TIP OF THE NEEDLE IS STILL EXPOSED. IT WILL CLICK MAKING YOU THINK IT'S LOCKED AND FULLY OVER THE NEEDLE WHEN IT ISN'T. THEY ARE ALSO EXTREMELY FLIMSY. THE NEEDLES FEEL AS IF THE SAFETY IS FULLY ENGAGED BUT A SMALL PART OF THE NEEDLE REMAINS UNSHEATHED. THEY ALSO NOTICED IF THE SAFETY IS PUSHED FURTHER TO ATTEMPT TO ENGAGE MORE, THE NEEDLE BEGINS TO BEND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18097413 ↗
• MalfunctionNov 8, 2023Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY ECRI, AN ANONYMOUS ECRI MEMBER REPORTED THAT THE SAFETY DOESN'T ENGAGE ALL THE WAY, SO THE TIP OF THE NEEDLE IS STILL EXPOSED. IT WILL CLICK MAKING YOU THINK IT'S LOCKED AND FULLY OVER THE NEEDLE WHEN IT ISN'T. THEY ARE ALSO EXTREMELY FLIMSY. THE NEEDLES FEEL AS IF THE SAFETY IS FULLY ENGAGED BUT A SMALL PART OF THE NEEDLE REMAINS UNSHEATHED. THEY ALSO NOTICED IF THE SAFETY IS PUSHED FURTHER TO ATTEMPT TO ENGAGE MORE, THE NEEDLE BEGINS TO BEND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18097407 ↗
• MalfunctionNov 8, 2023Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY ECRI, AN ANONYMOUS ECRI MEMBER REPORTED THAT THE SAFETY DOESN'T ENGAGE ALL THE WAY, SO THE TIP OF THE NEEDLE IS STILL EXPOSED. IT WILL CLICK MAKING YOU THINK IT'S LOCKED AND FULLY OVER THE NEEDLE WHEN IT ISN'T. THEY ARE ALSO EXTREMELY FLIMSY. THE NEEDLES FEEL AS IF THE SAFETY IS FULLY ENGAGED BUT A SMALL PART OF THE NEEDLE REMAINS UNSHEATHED. THEY ALSO NOTICED IF THE SAFETY IS PUSHED FURTHER TO ATTEMPT TO ENGAGE MORE, THE NEEDLE BEGINS TO BEND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18097404 ↗
• MalfunctionNov 8, 2023Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY ECRI, AN ANONYMOUS ECRI MEMBER REPORTED THAT THE SAFETY DOESN'T ENGAGE ALL THE WAY, SO THE TIP OF THE NEEDLE IS STILL EXPOSED. IT WILL CLICK MAKING YOU THINK IT'S LOCKED AND FULLY OVER THE NEEDLE WHEN IT ISN'T. THEY ARE ALSO EXTREMELY FLIMSY. THE NEEDLES FEEL AS IF THE SAFETY IS FULLY ENGAGED BUT A SMALL PART OF THE NEEDLE REMAINS UNSHEATHED. THEY ALSO NOTICED IF THE SAFETY IS PUSHED FURTHER TO ATTEMPT TO ENGAGE MORE, THE NEEDLE BEGINS TO BEND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18097398 ↗
• MalfunctionApr 21, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT WHILE DRAWING UP A VACCINE FROM A VIAL, THERE MUST HAVE BEEN TOO MUCH PRESSURE AND THE SYRINGE BACKED OFF THE NEEDLE AND VACCINE WENT ALL OVER THE PLACE, COULD SAY IT "EXPLODED". ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT WHEN DRAWING UP THE MMR VACCINE INTO THE SYRINGE, IT FELT A LITTLE MORE DIFFICULT, ALMOST LIKE THERE WAS A PULL FROM THE OTHER DIRECTION, BUT THE VACCINE WAS STILL SLOWLY PULLING TO THE SYRINGE AND THE PLUNGER WAS MOVING AND SUDDENLY, THE NEEDLE BACKED OFF THE SYRINGE AND PUSHED THE SYRINGE AWAY FROM THE NEEDLE; VACCINE BLEW OUT OF THE SYRINGE AND NEEDLE. THE NEEDLE WAS STILL IN THE VIAL STOPPER AND THE SYRINGE WAS LYING ON THE COUNTER AND FELT AS IF THERE WAS TOO MUCH PRESSURE IN THE VIAL OR SYRINGE. THERE WAS NO HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14177254 ↗