Magellan 8881882712Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20884521005911), received between Dec 9, 2019 and Nov 25, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE RN STATED THEY WERE PUSHING THE SAFETY OF THE INSULIN SYRINGE AND IT WENT TO THE SIDE, ACCIDENTLY POKING PINKY FINGER. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23647124 ↗
• InjuryJan 28, 2021Human-Device Interface Problem; Fail-Safe Did Not Operate; Human-Device Interface Problem; Fail-Safe Did Not Operate

  THE CUSTOMER REPORTED THAT THE SAFETY DEVICE THAT MUST BE PUSHED UP THE NEEDLE AFTER ADMINISTRATION WAS BLOCKED, REMAINING STUCK AT THE BOTTOM, UNABLE TO SECURE THE NEEDLE. WHEN THE STAFF WANTED TO RE-CAP THE NEEDLE (WHICH IS CONTRAINDICATED, SHE WAS TOLD AND WELL AWARE OF THIS) BUT THE NEEDLE PIERCED THE CAP AND SHE PRICKED HERSELF.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11248051 ↗
• InjuryNov 17, 2020Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED AFTER ADMINISTRATION OF HEPARIN SUBCUTANEOUS, THE NURSE CLOSED THE SAFETY SHIELD USING THE THUMB METHOD. THE RN WAS AWARE THE SHIELD ENGAGED, BUT THE SHIELD DISENGAGED, CAME BACK EXPOSING THE NEEDLE, AND THE NURSE WAS STUCK. THE NURSE REPORTED TO EMPLOYEE HEALTH AND NEEDLE STICK PROTOCOL WAS FOLLOWED. THE SITE OF THE NEEDLE STICK WAS CLEANED AND LABS WERE OBTAINED ON THE PATIENT. ALL THE PATIENTS TESTS WERE NEGATIVE AND NO FOLLOW UP IS SCHEDULED FOR THE NURSE AT THIS TIME.

  Patient problems: Needle Stick/Puncture

  MAUDE report 10851823 ↗
• MalfunctionJan 14, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE CUSTOMER REPORTED THAT THEY ATTEMPTED TO GIVE A PATIENT LOVENOX BUT IT WOULD NOT INJECT. WHEN THEY REMOVED THE NEEDLE FROM THE PATIENT AND LOOKED AT IT CLOSER, THE HEALTH CARE PROVIDER WAS ABLE TO PULL THE PLUNGER BACK BUT WHEN THEY PUSHED IT FORWARD IT WOULD NOT INJECT. THEY TRIED TO LOOK FOR ANY OCCLUSION AND COULD NOT SEE ANY. THE PLUNGER WOULD PULL BACK TO ASPIRATE, BUT WOULD NOT MOVE FORWARD TO INJECT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9588855 ↗
• InjuryDec 9, 2019Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  ON (B)(6) 2019 ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE NEEDLE HAD BEEN USED PRIOR TO THE NEEDLE STICK THEREFORE THE NEEDLE WAS CONTAMINATED. THE PERSONNEL IS DOING WELL AND WILL BE MONITORED THROUGH SEROLOGIC STUDIES.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9439221 ↗