Magellan 8881892910Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521005938), received between Dec 9, 2019 and May 2, 2024 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Problem” (7 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.

• MalfunctionMay 2, 2024Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE SAFETY DEVICE DOES NOT ALWAYS ACTIVATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19234821 ↗
• MalfunctionOct 5, 2022Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT 2 OUT OF 4 OR 5 INSULIN SYRINGES THAT THEY RECENTLY RECEIVED ARE JUST NOT RIGHT. IT IS LIKE PART OF THE SAFETY DEVICE IS ALREADY PARTLY ENGAGED WHEN CAP IS REMOVED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15543015 ↗
• MalfunctionOct 5, 2022Detachment of Device or Device Component; Fail-Safe Problem; Detachment of Device or Device Component; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE ENTIRE NEEDLE AND SAFETY DEVICE FELL OFF WHEN TRYING TO ENGAGE THE SAFETY DEVICE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15542715 ↗
• MalfunctionAug 10, 2022Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT WHEN THE NURSE PULLING OUT THE ORANGE CAP AND THE SAFETY GUIDE WAS ALSO PULLING OUT MAKING THE SYRINGE NOT USABLE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE ORANGE CAP WAS NOT HARD TO PULL. PER CUSTOMER, THE ENTIRE SAFETY MECHANISM WAS STICKING OUT ABOVE WHITE SAFETY GUARD WHEN PULLING OUT THE CAP. THERE WAS NO PATIENT INVOLVED AND NO INJURIES REPORTED. THE ISSUE WAS DISCOVERED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15203980 ↗
• MalfunctionAug 2, 2022Detachment of Device or Device Component; Protective Measures Problem

  THE CUSTOMER REPORTED WHEN THE NURSE PULLS OFF THE ORANGE CAP, THE SAFETY GUIDE ALSO PULLS OUT, MAKING THE SYRINGE UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15146302 ↗
• MalfunctionJan 31, 2022Break; Break

  THE CUSTOMER REPORTED ABOUT 16-20 NEEDLES PER BOX ARE BREAKING WHEN THE CAP IS REMOVED. IT APPEARS THE NEEDLE IS ALREADY OUT OF THE SYRINGE WHEN IT IS UNCAPPED, NOT THAT IT'S BEING PULLED OUT BY THE CAP. IT IS STILL ATTACHED TO THE SYRINGE BY A THIN WIRE. THERE HAS BEEN NO PATIENT OR STAFF HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13392484 ↗
• MalfunctionMay 24, 2021Fail-Safe Problem; Fail-Safe Problem

  CUSTOMER REPORTS: WE HAVE EXPERIENCED SEVERAL INCIDENCES OF THE SAFETY NOT ACTIVATING. THE PLASTIC WAS BENT AT THE END MAKING IT DIFFICULT TO DEPLOY SAFELY.

  Patient problems: Insufficient Information

  MAUDE report 11872363 ↗
• MalfunctionMay 24, 2021Fail-Safe Problem; Fail-Safe Problem

  CUSTOMER REPORTS: WE HAVE EXPERIENCED SEVERAL INCIDENCES OF THE SAFETY NOT ACTIVATING. THE PLASTIC WAS BENT AT THE END MAKING IT DIFFICULT TO DEPLOY SAFELY.

  Patient problems: Insufficient Information

  MAUDE report 11872086 ↗
• InjuryMay 21, 2021Fail-Safe Problem; Fail-Safe Problem

  CUSTOMER REPORTS: THERE WAS A NEEDLE STICK CAUSED FROM THE SAFETY DEVICE NOT ACTIVATING. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER STATED THAT THE NURSE WAS STUCK BY THE NEEDLE AFTER SHE HAD ADMINISTERED A INSULIN VACCINATION. THE NURSE HAD TO UNDERGO LAB TESTING AS A RESULT OF THE NEEDLE STICK AND THE TESTS RESULTS ARE PENDING.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11866687 ↗
• InjuryJan 28, 2021Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  THE CUSTOMER STATED THAT A STAFF MEMBER EXPERIENCED A NEEDLE STICK AFTER HE INJECTED A COVID PATIENT WITH INSULIN. THE STAFF MEMBER USED THE SAFETY BUT IT DID NOT CLICK IN ALL THE WAY. THE STAFF MEMBER THOUGHT HE HAD HEARD THE CLICK. THE STAFF MEMBER WENT TO OHS IN THE MORNING.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11248120 ↗
• MalfunctionSep 16, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE CUSTOMER STATES THERE IS A DOT OF GLUE ON THE NEEDLES PRIOR TO USE.

  Patient problems: No Patient Involvement

  MAUDE report 10544248 ↗
• MalfunctionDec 9, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THE CUSTOMER REPORTED A PRINT ISSUE. UPON INVESTIGATION ON 03-DEC-2019, TWENTY-TWO (22) SAMPLES WERE FOUND TO HAVE TWO OR MORE NON PRINTED OR ILLEGIBLE GRADUATIONS AND OR NUMERALS.

  Patient problems: No Patient Involvement

  MAUDE report 9438496 ↗