Magellan 8881892950Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521005945), received between Oct 31, 2018 and Aug 7, 2025 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Problem” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2025Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THEY HAD AN ACCIDENTAL NEEDLESTICK INCIDENT INVOLVING SYRINGE MODEL 8881892950 DISPENSED BY PHARMACY FOR LONG-ACTING INSULIN ADMINISTRATION. THE CORE SAFETY CONCERN IS THAT THE NEEDLE GUARD ON THIS SYRINGE DOES NOT ENGAGE SMOOTHLY. INITIALLY, IT SLIDES UP AND APPEARS TO STOP, WHICH CAN GIVE THE IMPRESSION THAT THE NEEDLE IS FULLY COVERED. HOWEVER, NURSES NEED TO APPLY ADDITIONAL FORCE BEYOND THIS INITIAL RESISTANCE TO FULLY ACTIVATE THE SAFETY GUARD AND PROPERLY COVER THE NEEDLE. THIS INCOMPLETE CLOSURE CREATES A RISK FOR ACCIDENTAL NEEDLESTICKS. ADDITIONAL INFORMATION RECEIVED ON 23JUL2025 STATED THAT THERE WAS NO MEDICAL TREATMENT NEEDED DUE TO IT BEING A CLEAN NEEDLE STICK.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22741860 ↗
• MalfunctionMar 6, 2024Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT TWO ASSOCIATES TESTED A CLEAN UNUSED NEEDLE. THEY ENGAGED THE SAFETY DEVICE AND HEARD THE "CLICK". THEY WENT TO DISPOSE OF THE SYRINGE AND THE SAFETY HAD SLID DOWN ENOUGH THAT THE NEEDLE WAS IN FACT UNCOVERED. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18848988 ↗
• MalfunctionMar 6, 2024Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE ASSOCIATE ENGAGED THE SAFETY DEVICE AND HEARD THE "CLICK". SHE WENT TO DISPOSE OF THE SYRINGE AND THE SAFETY HAD SLID DOWN ENOUGH THAT THE NEEDLE WAS IN FACT UNCOVERED. THIS RESULTED IN A DIRTY NEEDLESTICK ON THE SIDE OF HER FINGER. ADDITIONAL INFORMATION RECEIVED ON 19FEB2024 STATED THAT NO FIRST AID OR PROPHYLACTIC TREATMENT WAS PROVIDED. THE ASSOCIATE DID HAVE BLOOD WORK DONE AND THEY HAVE THE RESULTS BUT THE INITIAL REPORTER DOES NOT HAVE ACCESS TO THAT INFORMATION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 18848506 ↗
• MalfunctionAug 18, 2022Nonstandard Device; Nonstandard Device

  THE CUSTOMER REPORTED THAT THE DEFECTIVE NEEDLE CAUSED A NURSE TO GET STUCK AS THE NEEDLE WENT THROUGH THE CAP AS WELL AS A SYRINGE WITH TWO NEEDLES.

  Patient problems: Needle Stick/Puncture

  MAUDE report 15254902 ↗
• InjuryDec 21, 2020Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE SAFETY LOCK DID NOT ENGAGE CORRECTLY AND THE NURSE WAS STUCK BY THE NEEDLE. THE RN WENT TO THE EMERGENCY DEPARTMENT FOR TESTING.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11051283 ↗
• InjuryDec 21, 2020Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE SAFETY LOCK DID NOT ENGAGE CORRECTLY AND THE NURSE WAS STUCK BY THE NEEDLE. THE RN WENT TO ED FOR TESTING. ADDITIONAL INFORMATION RECEIVED STATED THE NEEDLE STICK OCCURRED WHEN THE NURSE WAS DISPOSING OF THE NEEDLE AFTER GIVING AN INSULIN INJECTION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11051266 ↗
• InjuryAug 31, 2020Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED, AFTER GIVING AN INSULIN INJECTION, THE NURSE PUSHED UP ON THE SAFETY SHIELD TO ACTIVATE IT AND THE NEEDLE BENT AT ABOUT A 90 DEGREE ANGLE AND PUNCTURED THROUGH THE SAFETY CAP STABBING THE NURSE'S INDEX FINGER. A BANDAGE WAS PLACED ON THE FINGER AND NO FURTHER TESTING WAS DONE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 10474084 ↗
• MalfunctionAug 11, 2020Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE INSULIN SYRINGE WAS FOUND BROKEN AT THE LEVEL OF THE NEEDLE AND THE SAFETY SHIELD IN THE PACKAGING. THE ISSUE WAS OBSERVED WITHOUT OPENING THE PACKAGE.

  Patient problems: No Patient Involvement

  MAUDE report 10393387 ↗
• InjuryFeb 17, 2020Activation Problem; Activation Problem

  THE CUSTOMER REPORTED THAT AFTER ADMINISTERING THE INSULIN, WHEN ACTIVATING THE SAFETY ON INSULIN SYRINGE IT JAMMED AND THE TIP OF THE NEEDLE PRICKED THE USERS PALM.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9717358 ↗
• InjuryAug 15, 2019Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE MAGELLAN INSULIN NEEDLE FLIPPED OUT OF THE SAFETY CAP CAUSING A NEEDLE STICK.

  Patient problems: Needle Stick/Puncture

  MAUDE report 8897454 ↗
• InjuryAug 15, 2019Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE MAGELLAN INSULIN NEEDLE FLIPPED OUT OF THE SAFETY CAP CAUSING A NEEDLE STICK.

  Patient problems: Needle Stick/Puncture

  MAUDE report 8897249 ↗
• MalfunctionOct 31, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THE CUSTOMER REPORTS: WHEN USING (OPENING THE CAP) IT WAS NOTICED, THAT A PIECE OF PLASTIC WAS STICKING AT THE NEEDLE (COLOR SIMILAR TO THE COLOR OF THE CAP).

  Patient problems: No Patient Involvement

  MAUDE report 8025256 ↗